Accepted Manuscript A New Approach in Fibromyalgia Exercise Program: A Preliminary Study Regarding the Effectiveness of Balance Training Sibel Kibar, MD, Assistant Professor, Hatice Ecem Yıldız, MD, Saime Ay, MD, Associate Professor, Deniz Evcik, MD, Professor, Emine Süreyya Ergin, MD, Professor PII:
S0003-9993(15)00416-5
DOI:
10.1016/j.apmr.2015.05.004
Reference:
YAPMR 56205
To appear in:
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
Received Date: 10 November 2014 Revised Date:
21 April 2015
Accepted Date: 11 May 2015
Please cite this article as: Kibar S, Yıldız HE, Ay S, Evcik D, Ergin ES, A New Approach in Fibromyalgia Exercise Program: A Preliminary Study Regarding the Effectiveness of Balance Training, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2015), doi: 10.1016/j.apmr.2015.05.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Running head: Balance Training in Fibromyalgia
Keywords: fibromiyalgia, balance, exercise
1
Hatice Ecem Yıldız, MD
1
Saime Ay ,MD, Associate Professor
2
Deniz Evcik ,MD, Professor
1
Emine Süreyya Ergin, MD, Professor
M AN U
Sibel Kibar, MD, Assistant Professor
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1
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Authors:
RI PT
Title: A New Approach in Fibromyalgia Exercise Program: A Preliminary Study Regarding the Effectiveness of Balance Training
Affiliations: 1
Department of Physical Medicine and Rehabilitation, Ufuk University School of Medicine, Ankara, Turkey
2
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EP
Department of Therapy and Rehabilitation, Ankara University Haymana Vocational School, Ankara, Turkey
Acknowledgement:
This study was presented as poster presentation in Annual European Congress of
Rheumatology, EULAR 2014, 11-14 June 2014 – Paris, FRANCE (EULAR14-SCIE-4211: Is Balance Training Exercise Program Effective in Fibromiyalgia Syndrome? )
ACCEPTED MANUSCRIPT Conflict of interest: The authors declare that they have no conflict of interest and no disclosures. The authors have full control of all primary data and agree to allow the journal to review the data if requested. We certify that no party having a direct interest in the results of the research
RI PT
supporting this article has or will confer a benefit on us or on any organization with which we are associated and, if applicable, we certify that all financial and material support for this research (eg, NIH or NHS grants) and work are clearly identified in the title page of the
SC
manuscript.
M AN U
The manuscript submitted does not contain information about medical device.
Corresponding author and Reprints: Sibel Kibar, MD
Adress: Department of Physical Medicine and Rehabilitation, Ufuk University, School of Medicine,Mevlana Bulvarı No88 Balgat, 06530, Çankaya, Ankara, Turkey
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Tel: 0090 5056888724, 0090 3122044355 e-mail: [email protected]
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EP
Clinical Trial Registration Number: 1506201221
Acknowledgements: We are indebted to our patients for their contributions,
and we also want to thank Miss Aslihan Alhan (statistician) for her statistical recommendations, Mr İbrahim Yılmazer and Dr. Timur Ekiz for their recommendations.
ACCEPTED MANUSCRIPT The software (The Predictive Analytics SoftWare (PASW) Statistics version 18.0) used in the present study supplied by Ufuk University School of Medicine. G-Power is
AC C
EP
TE D
M AN U
SC
RI PT
a free software on internet.
ACCEPTED MANUSCRIPT
A New Approach in Fibromyalgia Exercise Program: A Preliminary Study
1 2
Regarding the Effectiveness of Balance Training Abstract
4
Objective: To determine the effectiveness of balance exercises on the functional
RI PT
3
level and quality of life(QoL)of patients with fibromyalgia syndrome (FMS) and investigate
6
the circumstances associated with balance disorders in FMS.
SC
5
Design:Randomized controlled trial
8
Setting: Physical medicine and rehabilitation clinic
9
Participants:Patients (age=18-65) with FMS were randomly assigned into two
12 13
TE D
11
groups.
Interventions: Group-1 was given flexibility and balance exercises for six weeks while group-2 received only flexibility program as the control group. Main Outcome Measures: Functional balance was measured by Berg Balance
EP
10
M AN U
7
Scale (BBS), dynamic and static balance were evaluated by Sport Kinesthetic Ability
15
Trainer (KAT) 4000 device. Fall risk was assessedwiththe Hendrich II Fall Risk Model.
16
Nottingham Health Profile, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression
17
Inventory (BDI) were used to determine QoL, functional and depression levels respectively.
18
Assessments were performed at the baseline and after six-week program.
19 20
AC C
14
Results: In group-1 (n=28), statistically significant improvements were observed in all parameters (p˂0.05), but no improvement was seen in group-2 (n=29) (p˃0.05). When
ACCEPTED MANUSCRIPT
comparing the two groups, there were significant differences in group-1concerningthe KAT
22
static balance test(p=0.017) and the FIQ measurements (p=0.005). In the correlation
23
analysis,the BDI was correlated with the BBS(r=-0.434) and HendrichII results (r=0.357),
24
whereas the BMI was correlated with the KATstatic balance measurements (r=0.433), BBS
25
(r=-0.285), and fall frequency (r=0.328).
26
Conclusions:A six-week balance training program had a beneficial effect on the static
27
balance and functional levelsof patients with FMS. We also observed that depression
28
deterioration was related to balance deficit and fall risk.Besides higher BMI wereassociated
29
with the balance deficit and fall frequency.
SC
M AN U
30
RI PT
21
Keywords: fibromyalgia, treatment, balance, exercise
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31
Abbreviations:
33
FMS: Fibromyalgia Syndrome
34
EULAR: European League Against Rheumatism
35
KAT: Kinesthetic Ability Trainer
36
ACSM: American College of Sports Medicine
38
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37
EP
32
BMI: Body Mass Index BBS: Berg Balance Scale
39
FIQ: Fibromyalgia Impact Questionnaire
40
QoL: Quality of Life
41
NHP: Nottingham Health Profile
ACCEPTED MANUSCRIPT
42
BDI: Beck Depression Inventory
43
Fibromyalgia syndrome (FMS) is a rheumatological disorder with clinical features such as widespread pain, fatigue, cognitive symptoms, and nonrestorative sleep.1 Up to 20%
45
of the patients presenting at rheumatology clinics and more than 10% seeking general
46
medical care have FMS;2 therefore, physicians should consider this syndrome in their usual
47
clinical practice.
SC
A variety of neurological signs and symptoms, for example dizziness, vertigo,
M AN U
48
RI PT
44
tingling, and burning, have been reported with FMS,3 and it is also associated with balance
50
problems and increased fall frequency.3,4 Recently, it was reported that balance deficit was
51
one of the 10 most debilitating symptoms of FMS, with a prevalence rate of 45%.5
52
Additionally, compared with healthy individuals, FMS patients with a balance disorder were
53
usually unaware of their problem.6 Thus, the daily living activities of those with FMS are
54
significantly decreased because of the balance deficit and inactivity caused by this
55
condition.
EP
The daily functional levels of FMS patients are also poor.6 Moreover, these patients
AC C
56
TE D
49
57
experience a reduction in cognitive functions compared with healthy controls,7 and various
58
pathological conditions, such as depression, headaches, and variable bowel habits may
59
occur concomitantly. Therefore, symptom-based treatment methods lead to polypharmacy.8
60
Formiga et al.9 found that the high numbers of geriatric patients with balance deficit who
61
experience falling also have weakened functional and cognitive statuses and use multiple
62
medications. Similarly, polypharmacy combined with cognitive impairment may also
ACCEPTED MANUSCRIPT
63
facilitate the balance deficit and falling in patients with FMS. However, it is still not clear
64
which of the associated risk factors are related to the balance deficit. Since the symptoms are patient-specific, the patients should be treated on an
66
individual basis.10 The European League Against Rheumatism (EULAR) has recommended
67
individually tailored exercise programs that include aerobic and strength exercises,11 but
68
only a few studies have focused on balance exercises. Sanudo et al. 12 investigated the effects
69
of whole body vibration training and found statistically significant improvements compared
70
to traditional methods. Additionally dynamic balance with tilt vibration exercises showed
71
positive effects on FMS.13
M AN U
SC
RI PT
65
However, Demir-Göçmen et al.10 found no significant differences between balance
73
and stretching exercises in FMS. In addition, since there have been previous reports which
74
stated that FMS may affect the peripheral and central mechanisms of postural control,4,14
75
more studies are needed to determine whether balance and exercise training can improve
76
postural stability and reduce the number of falls in FMS patients.
EP
TE D
72
AC C
In this study, we aimed to assess the effectiveness of balance training in FMS
77 78
exercise program and investigate the circumstances associated with balance disorders in
79
FMS.
80
81
Methods
Participants:
ACCEPTED MANUSCRIPT
82
Seventy-seven patients between the ages of 18-65 with FMS were evaluated by an experienced physiatrist between 2011 and 2013. The FMS diagnosis was based on the 2010
84
American College of Rheumatology (ACR) diagnostic criteria.1 Prospective participants
85
with vitamin-B12, 25OHvitamin-D, and folate deficiencies, diabetes mellitus, neurological
86
diseases, rheumatoid diseases, eye and internal ear pathologies , advanced cardiovascular or
87
lung pathologies and those with uncontrolled hypertension or hypotension were excluded. In
88
addition, patients who previously underwent surgery or had injuries in their lower
89
extremities (knees, hips, ankles, feet) as well as those admitted to a physical therapy and/or
90
an exercise program for their pain within the last year were also not included.
SC
M AN U
91
RI PT
83
A researcher who was unaware of the treatment procedures used a computer program to randomly assign the patients to one of two groups using their patient record
93
numbers. The enrollment and allocation process is shown in Figure 1.
94
TE D
92
Group1 was given balance exercises along with dynamic and static balance training on the Sports Kinesthetic Ability Trainer (KAT) 4000 device (SportKAT LLC., Fallbrook,
96
CA., USA) and flexibility exercises. Group2 received only flexibility exercises.
AC C
97
EP
95
Two other experienced physiatrists who were blinded to the groups performed
98
evaluations at the baseline and after six-week exercise program, and all participants were
99
asked to provide no information to the examiner about their treatment protocol. Patients
100
using antidepressants or anti-epileptic drugs for more than three months were allowed to
101
continue, but they could take no new drugs other than paracetamol during the study. This
102
research was carried out in accordance with the Declaration of Helsinki and was approved
ACCEPTED MANUSCRIPT
103
by the research committee of the ………….University School of Medicine. Furthermore,
104
written consent for inclusion in the study was obtained from all of the patients.
106
RI PT
105
Exercise Procedures:
107
Balance exercises: Group1 received balance exercises as recommended by the
SC
108
American College of Sports Medicine (ACSM).15 These included postures that gradually
110
reduced the base of support (two-legged stand, semi-tandem, tandem, one-legged stand),
111
dynamic movements that disturbed the center of gravity (tandem walk or circle turns),
112
exercises that stressed the postural muscle groups (heel or toe stands),and those that reduced
113
sensory input (standing with one’s eyes closed).15 Training was provided by an experienced
114
physiotherapist for 20 sessions over a four-week period (20 minutes for each session; five
115
days a week)
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109
KAT balance training:Group1 also received five minutes of static and five minutes
117
of dynamic balance training with KAT device three days a week. This device has a movable
118
platform and a tilt sensor that is connected to a computer. The subjects maintained their
119
balance by tilting the platform in all directions without moving their feet. They could only
120
change their center of gravity via trunk movements. During the static balance training, the
121
patients were asked to maintain their equilibrium while standing as motionless as possible
122
on the platform and were told to keep the red “X”symbol in the center of the computer
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116
ACCEPTED MANUSCRIPT
123
screen. In the dynamic balance training, they were asked to superimpose the “X” onto the
124
moving cursor while it made a 360° circle on the screen.
RI PT
125 126
Flexibility exercises:
127
Only active static exercises were preferred in order to enable compliance to exercise and its maintenance without being forced in fibromyalgia patients, who have fatigue and
129
depression. Exercises were performed in eight large muscle groups (neck, back, lower-back,
130
biceps, triceps, gluteus, iliopsoas, quadriceps femoris, hamstring, gastrosoleus) in three 60-
131
seconds static stretching repetitions.16 Since in older persons, holding a stretch for 30–60
132
second may confer greater benefit, for each muscle, to the extent that patients was capable,
133
30-60 second static stretching was carried out. This protocol was used in the same manner
134
in all patients. Ten minutes of walking in place was also recommended as warm-up for the
135
stretching exercises. Group1 performed these flexibility exercises under the supervision of a
136
physiotherapist throughout the entire program. Group2 performed the flexibility exercises
137
for only two sessions and were informed about the necessity of exercising five days a week.
138
The patient’s attendance was monitored by the physiotherapist, and all of the patients
139
received weekly telephone calls to ensure that they were achieving the needed 80%
140
participation required for a successful study.
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SC
128
141
Assessment Parameters:
142
The patients’ sociodemographic data (age, gender), education levels, and working
143
status were recorded. After measuring their weight and height, the body mass index (BMI
ACCEPTED MANUSCRIPT
144
:(W-kg)/H2-m2) was calculated. Furthermore, any use of antidepressants or anti-epileptic
145
drugs was also noted. Balance and Fall Evaluation
147
To establish a fall history, we conducted an interview in which the patients
RI PT
146
estimated how many times they had fallen in the preceding year. A fall was defined as
149
unintentionally coming to rest on the ground, floor, or other lower level either with or
150
without an injury.17
M AN U
151
SC
148
The Berg Balance Scale (BBS), was utilized to assess functional balance.18 It consists of 14 items that measure static balance (e,g., standing unsupported and single leg
153
stand), dynamic balance, and functional assessment during commonly performed daily
154
activities like reaching forward, standing up from a sitting position, and retrieving objects
155
from the floor.18 It uses a five-point scoring scale with a maximum of 56 possible points. A
156
score between 0-20 indicates a high fall risk, 21-40 points indicates moderate, and 41-56
157
points indicates a low fall risk. The validity and reliability of the Turkish version of the BBS
158
was proven.19
EP
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159
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152
Dynamic and static balances were evaluated using the KAT device. The patients
160
were asked to stand barefoot on the platform, and a computer screen was positioned directly
161
in front of them to provide concurrent biofeedback on their position. Each test lasted for 30
162
seconds and was repeated three times, with the highest score being accepted as the final
163
score. Increased measurements indicated a poor balance performance.20
ACCEPTED MANUSCRIPT
164
The Hendrich II Fall Risk Model was used to evaluate the risk of fall, and it includes various risk factors such as confusion , depression , changes at discharge, vertigo,
166
male gender, the use of anti-epileptics and benzodiazepines, and the standing up and
167
walking test. A total score≥ 5 indicated a fall risk.21 The validity and reliability of the
168
Turkish version of this model was also previously verified.22
SC
169
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165
Clinical Measurements
171
The Fibromyalgia Impact Questionnaire (FIQ), a self-administered instrument,
M AN U
170
was used to evaluate functional status, progress, and outcomes.23 It is composed of 10 items
173
with a maximum score of 10: physical functioning, daily activities, housework, work
174
difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Higher scores
175
signifying greater impairment. The Turkish version of the FIQ was previously validated.24
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172
Quality of life(QoL) was measured via the Turkish version of the Nottingham
177
Health Profile(NHP),25 which is designed to give a brief indication of perceived physical,
178
social, and emotional health problems.26 The newest version consists of 38 items in which
179
the patients answer “Yes” or “No” according to whether or not they believe the item is
180
applicable to them.27
181 182
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176
The Beck Depression Inventory(BDI) was used to assess the depression levels of the patients.28 The BDI evaluates 21 symptoms of depression, 15 of which deal with
ACCEPTED MANUSCRIPT
emotions, four with behavioral changes, and six with somatic symptoms. Each symptom is
184
rated on a four-point intensity scale. Higher scores indicate more severe depression. The
185
validity and reliability of the Turkish version was verified before.29
RI PT
183
Statistical Analysis:
187
The Predictive Analytics SoftWare (PASW) Statistics version 18.0 for Windows
SC
186
software program (SPSS, Inc., Chicago, IL, USA) was used for all statistical analyses. The
189
mean values and frequencies of the parameters were assessed using descriptive statistics,
190
and the normality of the variables was analyzed via the Kolmogorov-Smirnov test. At the
191
baseline, the differences between the groups were tested using an independent samples t-test
192
and Mann-Whitney-U test. A paired sample t-test was used to evaluate the intragroup
193
comparisons. We compared the results between two groups by using an independent
194
samples t-test. Pearson’s correlation analysis was used to determine the relation between the
195
balance parameters and the other variables. A p value of
S0003-9993(15)00416-5
DOI:
10.1016/j.apmr.2015.05.004
Reference:
YAPMR 56205
To appear in:
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
Received Date: 10 November 2014 Revised Date:
21 April 2015
Accepted Date: 11 May 2015
Please cite this article as: Kibar S, Yıldız HE, Ay S, Evcik D, Ergin ES, A New Approach in Fibromyalgia Exercise Program: A Preliminary Study Regarding the Effectiveness of Balance Training, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2015), doi: 10.1016/j.apmr.2015.05.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Running head: Balance Training in Fibromyalgia
Keywords: fibromiyalgia, balance, exercise
1
Hatice Ecem Yıldız, MD
1
Saime Ay ,MD, Associate Professor
2
Deniz Evcik ,MD, Professor
1
Emine Süreyya Ergin, MD, Professor
M AN U
Sibel Kibar, MD, Assistant Professor
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1
SC
Authors:
RI PT
Title: A New Approach in Fibromyalgia Exercise Program: A Preliminary Study Regarding the Effectiveness of Balance Training
Affiliations: 1
Department of Physical Medicine and Rehabilitation, Ufuk University School of Medicine, Ankara, Turkey
2
AC C
EP
Department of Therapy and Rehabilitation, Ankara University Haymana Vocational School, Ankara, Turkey
Acknowledgement:
This study was presented as poster presentation in Annual European Congress of
Rheumatology, EULAR 2014, 11-14 June 2014 – Paris, FRANCE (EULAR14-SCIE-4211: Is Balance Training Exercise Program Effective in Fibromiyalgia Syndrome? )
ACCEPTED MANUSCRIPT Conflict of interest: The authors declare that they have no conflict of interest and no disclosures. The authors have full control of all primary data and agree to allow the journal to review the data if requested. We certify that no party having a direct interest in the results of the research
RI PT
supporting this article has or will confer a benefit on us or on any organization with which we are associated and, if applicable, we certify that all financial and material support for this research (eg, NIH or NHS grants) and work are clearly identified in the title page of the
SC
manuscript.
M AN U
The manuscript submitted does not contain information about medical device.
Corresponding author and Reprints: Sibel Kibar, MD
Adress: Department of Physical Medicine and Rehabilitation, Ufuk University, School of Medicine,Mevlana Bulvarı No88 Balgat, 06530, Çankaya, Ankara, Turkey
TE D
Tel: 0090 5056888724, 0090 3122044355 e-mail: [email protected]
AC C
EP
Clinical Trial Registration Number: 1506201221
Acknowledgements: We are indebted to our patients for their contributions,
and we also want to thank Miss Aslihan Alhan (statistician) for her statistical recommendations, Mr İbrahim Yılmazer and Dr. Timur Ekiz for their recommendations.
ACCEPTED MANUSCRIPT The software (The Predictive Analytics SoftWare (PASW) Statistics version 18.0) used in the present study supplied by Ufuk University School of Medicine. G-Power is
AC C
EP
TE D
M AN U
SC
RI PT
a free software on internet.
ACCEPTED MANUSCRIPT
A New Approach in Fibromyalgia Exercise Program: A Preliminary Study
1 2
Regarding the Effectiveness of Balance Training Abstract
4
Objective: To determine the effectiveness of balance exercises on the functional
RI PT
3
level and quality of life(QoL)of patients with fibromyalgia syndrome (FMS) and investigate
6
the circumstances associated with balance disorders in FMS.
SC
5
Design:Randomized controlled trial
8
Setting: Physical medicine and rehabilitation clinic
9
Participants:Patients (age=18-65) with FMS were randomly assigned into two
12 13
TE D
11
groups.
Interventions: Group-1 was given flexibility and balance exercises for six weeks while group-2 received only flexibility program as the control group. Main Outcome Measures: Functional balance was measured by Berg Balance
EP
10
M AN U
7
Scale (BBS), dynamic and static balance were evaluated by Sport Kinesthetic Ability
15
Trainer (KAT) 4000 device. Fall risk was assessedwiththe Hendrich II Fall Risk Model.
16
Nottingham Health Profile, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression
17
Inventory (BDI) were used to determine QoL, functional and depression levels respectively.
18
Assessments were performed at the baseline and after six-week program.
19 20
AC C
14
Results: In group-1 (n=28), statistically significant improvements were observed in all parameters (p˂0.05), but no improvement was seen in group-2 (n=29) (p˃0.05). When
ACCEPTED MANUSCRIPT
comparing the two groups, there were significant differences in group-1concerningthe KAT
22
static balance test(p=0.017) and the FIQ measurements (p=0.005). In the correlation
23
analysis,the BDI was correlated with the BBS(r=-0.434) and HendrichII results (r=0.357),
24
whereas the BMI was correlated with the KATstatic balance measurements (r=0.433), BBS
25
(r=-0.285), and fall frequency (r=0.328).
26
Conclusions:A six-week balance training program had a beneficial effect on the static
27
balance and functional levelsof patients with FMS. We also observed that depression
28
deterioration was related to balance deficit and fall risk.Besides higher BMI wereassociated
29
with the balance deficit and fall frequency.
SC
M AN U
30
RI PT
21
Keywords: fibromyalgia, treatment, balance, exercise
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31
Abbreviations:
33
FMS: Fibromyalgia Syndrome
34
EULAR: European League Against Rheumatism
35
KAT: Kinesthetic Ability Trainer
36
ACSM: American College of Sports Medicine
38
AC C
37
EP
32
BMI: Body Mass Index BBS: Berg Balance Scale
39
FIQ: Fibromyalgia Impact Questionnaire
40
QoL: Quality of Life
41
NHP: Nottingham Health Profile
ACCEPTED MANUSCRIPT
42
BDI: Beck Depression Inventory
43
Fibromyalgia syndrome (FMS) is a rheumatological disorder with clinical features such as widespread pain, fatigue, cognitive symptoms, and nonrestorative sleep.1 Up to 20%
45
of the patients presenting at rheumatology clinics and more than 10% seeking general
46
medical care have FMS;2 therefore, physicians should consider this syndrome in their usual
47
clinical practice.
SC
A variety of neurological signs and symptoms, for example dizziness, vertigo,
M AN U
48
RI PT
44
tingling, and burning, have been reported with FMS,3 and it is also associated with balance
50
problems and increased fall frequency.3,4 Recently, it was reported that balance deficit was
51
one of the 10 most debilitating symptoms of FMS, with a prevalence rate of 45%.5
52
Additionally, compared with healthy individuals, FMS patients with a balance disorder were
53
usually unaware of their problem.6 Thus, the daily living activities of those with FMS are
54
significantly decreased because of the balance deficit and inactivity caused by this
55
condition.
EP
The daily functional levels of FMS patients are also poor.6 Moreover, these patients
AC C
56
TE D
49
57
experience a reduction in cognitive functions compared with healthy controls,7 and various
58
pathological conditions, such as depression, headaches, and variable bowel habits may
59
occur concomitantly. Therefore, symptom-based treatment methods lead to polypharmacy.8
60
Formiga et al.9 found that the high numbers of geriatric patients with balance deficit who
61
experience falling also have weakened functional and cognitive statuses and use multiple
62
medications. Similarly, polypharmacy combined with cognitive impairment may also
ACCEPTED MANUSCRIPT
63
facilitate the balance deficit and falling in patients with FMS. However, it is still not clear
64
which of the associated risk factors are related to the balance deficit. Since the symptoms are patient-specific, the patients should be treated on an
66
individual basis.10 The European League Against Rheumatism (EULAR) has recommended
67
individually tailored exercise programs that include aerobic and strength exercises,11 but
68
only a few studies have focused on balance exercises. Sanudo et al. 12 investigated the effects
69
of whole body vibration training and found statistically significant improvements compared
70
to traditional methods. Additionally dynamic balance with tilt vibration exercises showed
71
positive effects on FMS.13
M AN U
SC
RI PT
65
However, Demir-Göçmen et al.10 found no significant differences between balance
73
and stretching exercises in FMS. In addition, since there have been previous reports which
74
stated that FMS may affect the peripheral and central mechanisms of postural control,4,14
75
more studies are needed to determine whether balance and exercise training can improve
76
postural stability and reduce the number of falls in FMS patients.
EP
TE D
72
AC C
In this study, we aimed to assess the effectiveness of balance training in FMS
77 78
exercise program and investigate the circumstances associated with balance disorders in
79
FMS.
80
81
Methods
Participants:
ACCEPTED MANUSCRIPT
82
Seventy-seven patients between the ages of 18-65 with FMS were evaluated by an experienced physiatrist between 2011 and 2013. The FMS diagnosis was based on the 2010
84
American College of Rheumatology (ACR) diagnostic criteria.1 Prospective participants
85
with vitamin-B12, 25OHvitamin-D, and folate deficiencies, diabetes mellitus, neurological
86
diseases, rheumatoid diseases, eye and internal ear pathologies , advanced cardiovascular or
87
lung pathologies and those with uncontrolled hypertension or hypotension were excluded. In
88
addition, patients who previously underwent surgery or had injuries in their lower
89
extremities (knees, hips, ankles, feet) as well as those admitted to a physical therapy and/or
90
an exercise program for their pain within the last year were also not included.
SC
M AN U
91
RI PT
83
A researcher who was unaware of the treatment procedures used a computer program to randomly assign the patients to one of two groups using their patient record
93
numbers. The enrollment and allocation process is shown in Figure 1.
94
TE D
92
Group1 was given balance exercises along with dynamic and static balance training on the Sports Kinesthetic Ability Trainer (KAT) 4000 device (SportKAT LLC., Fallbrook,
96
CA., USA) and flexibility exercises. Group2 received only flexibility exercises.
AC C
97
EP
95
Two other experienced physiatrists who were blinded to the groups performed
98
evaluations at the baseline and after six-week exercise program, and all participants were
99
asked to provide no information to the examiner about their treatment protocol. Patients
100
using antidepressants or anti-epileptic drugs for more than three months were allowed to
101
continue, but they could take no new drugs other than paracetamol during the study. This
102
research was carried out in accordance with the Declaration of Helsinki and was approved
ACCEPTED MANUSCRIPT
103
by the research committee of the ………….University School of Medicine. Furthermore,
104
written consent for inclusion in the study was obtained from all of the patients.
106
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Exercise Procedures:
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Balance exercises: Group1 received balance exercises as recommended by the
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American College of Sports Medicine (ACSM).15 These included postures that gradually
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reduced the base of support (two-legged stand, semi-tandem, tandem, one-legged stand),
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dynamic movements that disturbed the center of gravity (tandem walk or circle turns),
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exercises that stressed the postural muscle groups (heel or toe stands),and those that reduced
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sensory input (standing with one’s eyes closed).15 Training was provided by an experienced
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physiotherapist for 20 sessions over a four-week period (20 minutes for each session; five
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days a week)
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KAT balance training:Group1 also received five minutes of static and five minutes
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of dynamic balance training with KAT device three days a week. This device has a movable
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platform and a tilt sensor that is connected to a computer. The subjects maintained their
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balance by tilting the platform in all directions without moving their feet. They could only
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change their center of gravity via trunk movements. During the static balance training, the
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patients were asked to maintain their equilibrium while standing as motionless as possible
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on the platform and were told to keep the red “X”symbol in the center of the computer
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screen. In the dynamic balance training, they were asked to superimpose the “X” onto the
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moving cursor while it made a 360° circle on the screen.
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Flexibility exercises:
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Only active static exercises were preferred in order to enable compliance to exercise and its maintenance without being forced in fibromyalgia patients, who have fatigue and
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depression. Exercises were performed in eight large muscle groups (neck, back, lower-back,
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biceps, triceps, gluteus, iliopsoas, quadriceps femoris, hamstring, gastrosoleus) in three 60-
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seconds static stretching repetitions.16 Since in older persons, holding a stretch for 30–60
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second may confer greater benefit, for each muscle, to the extent that patients was capable,
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30-60 second static stretching was carried out. This protocol was used in the same manner
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in all patients. Ten minutes of walking in place was also recommended as warm-up for the
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stretching exercises. Group1 performed these flexibility exercises under the supervision of a
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physiotherapist throughout the entire program. Group2 performed the flexibility exercises
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for only two sessions and were informed about the necessity of exercising five days a week.
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The patient’s attendance was monitored by the physiotherapist, and all of the patients
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received weekly telephone calls to ensure that they were achieving the needed 80%
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participation required for a successful study.
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Assessment Parameters:
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The patients’ sociodemographic data (age, gender), education levels, and working
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status were recorded. After measuring their weight and height, the body mass index (BMI
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:(W-kg)/H2-m2) was calculated. Furthermore, any use of antidepressants or anti-epileptic
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drugs was also noted. Balance and Fall Evaluation
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To establish a fall history, we conducted an interview in which the patients
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estimated how many times they had fallen in the preceding year. A fall was defined as
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unintentionally coming to rest on the ground, floor, or other lower level either with or
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without an injury.17
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The Berg Balance Scale (BBS), was utilized to assess functional balance.18 It consists of 14 items that measure static balance (e,g., standing unsupported and single leg
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stand), dynamic balance, and functional assessment during commonly performed daily
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activities like reaching forward, standing up from a sitting position, and retrieving objects
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from the floor.18 It uses a five-point scoring scale with a maximum of 56 possible points. A
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score between 0-20 indicates a high fall risk, 21-40 points indicates moderate, and 41-56
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points indicates a low fall risk. The validity and reliability of the Turkish version of the BBS
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was proven.19
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Dynamic and static balances were evaluated using the KAT device. The patients
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were asked to stand barefoot on the platform, and a computer screen was positioned directly
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in front of them to provide concurrent biofeedback on their position. Each test lasted for 30
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seconds and was repeated three times, with the highest score being accepted as the final
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score. Increased measurements indicated a poor balance performance.20
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The Hendrich II Fall Risk Model was used to evaluate the risk of fall, and it includes various risk factors such as confusion , depression , changes at discharge, vertigo,
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male gender, the use of anti-epileptics and benzodiazepines, and the standing up and
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walking test. A total score≥ 5 indicated a fall risk.21 The validity and reliability of the
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Turkish version of this model was also previously verified.22
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Clinical Measurements
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The Fibromyalgia Impact Questionnaire (FIQ), a self-administered instrument,
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was used to evaluate functional status, progress, and outcomes.23 It is composed of 10 items
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with a maximum score of 10: physical functioning, daily activities, housework, work
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difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Higher scores
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signifying greater impairment. The Turkish version of the FIQ was previously validated.24
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Quality of life(QoL) was measured via the Turkish version of the Nottingham
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Health Profile(NHP),25 which is designed to give a brief indication of perceived physical,
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social, and emotional health problems.26 The newest version consists of 38 items in which
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the patients answer “Yes” or “No” according to whether or not they believe the item is
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applicable to them.27
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The Beck Depression Inventory(BDI) was used to assess the depression levels of the patients.28 The BDI evaluates 21 symptoms of depression, 15 of which deal with
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emotions, four with behavioral changes, and six with somatic symptoms. Each symptom is
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rated on a four-point intensity scale. Higher scores indicate more severe depression. The
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validity and reliability of the Turkish version was verified before.29
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Statistical Analysis:
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The Predictive Analytics SoftWare (PASW) Statistics version 18.0 for Windows
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software program (SPSS, Inc., Chicago, IL, USA) was used for all statistical analyses. The
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mean values and frequencies of the parameters were assessed using descriptive statistics,
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and the normality of the variables was analyzed via the Kolmogorov-Smirnov test. At the
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baseline, the differences between the groups were tested using an independent samples t-test
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and Mann-Whitney-U test. A paired sample t-test was used to evaluate the intragroup
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comparisons. We compared the results between two groups by using an independent
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samples t-test. Pearson’s correlation analysis was used to determine the relation between the
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balance parameters and the other variables. A p value of
