Back to resultsComparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia. (FMS)
Primary Purpose
Fibromyalgia Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapeutic exercises
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18 and 60,
- Symptoms lasting longer than 3 months,
- According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
- According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
- Acceptance of treatment that will continue 3 days a week for 6 weeks,
- The possibility of any change in medical treatment due to FMS during the study is not foreseen.
Exclusion Criteria:
- Known central or peripheral nervous system disease, progressive neurological damage,
- Any serious cardiovascular pathology,
- Sense, loss of sense of position, unhealed fracture or a surgical wound,
- Presence of uncontrolled hypertension,
- Failure to understand or perform simple commands.
Sites / Locations
- İstanbul Faculty of Medicine, Department of Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
balance-proprioception exercises group
aerobic exercises group
Arm Description
balance-proprioception exercises group
aerobic exercises group
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ)
In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.
Pain (Visual Analogue Scale)
Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.
Muscle Strength Evaluation
The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04437524
Brief Title
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.
Acronym
FMS
Official Title
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.
Detailed Description
In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
balance-proprioception exercises group
Arm Type
Active Comparator
Arm Description
balance-proprioception exercises group
Arm Title
aerobic exercises group
Arm Type
Active Comparator
Arm Description
aerobic exercises group
Intervention Type
Other
Intervention Name(s)
therapeutic exercises
Intervention Description
Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.
Time Frame
6 weeks
Title
Pain (Visual Analogue Scale)
Description
Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.
Time Frame
6 weeks
Title
Muscle Strength Evaluation
Description
The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female fibromyalgia patients will be admitted to the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 18 and 60,
Symptoms lasting longer than 3 months,
According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
Acceptance of treatment that will continue 3 days a week for 6 weeks,
The possibility of any change in medical treatment due to FMS during the study is not foreseen.
Exclusion Criteria:
Known central or peripheral nervous system disease, progressive neurological damage,
Any serious cardiovascular pathology,
Sense, loss of sense of position, unhealed fracture or a surgical wound,
Presence of uncontrolled hypertension,
Failure to understand or perform simple commands.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökhan Metin, Professor
Organizational Affiliation
İstanbul Univesity, İstanbul Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul Faculty of Medicine, Department of Sports Medicine
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.
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