FMS: Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04437524

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

15.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Other: therapeutic exercises	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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).

Actual Study Start Date :

Aug 24, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: balance-proprioception exercises group balance-proprioception exercises group	Other: therapeutic exercises Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
Active Comparator: aerobic exercises group aerobic exercises group	Other: therapeutic exercises Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

Arm

Intervention/Treatment

Active Comparator: balance-proprioception exercises group

balance-proprioception exercises group

Other: therapeutic exercises

Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

Active Comparator: aerobic exercises group

aerobic exercises group

Other: therapeutic exercises

Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

Outcome Measures

Primary Outcome Measures

Fibromyalgia Impact Questionnaire (FIQ) [6 weeks]
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) [6 weeks]
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 [6 weeks]
The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	İstanbul Faculty of Medicine, Department of Sports Medicine	Istanbul		Turkey

Sponsors and Collaborators

Istanbul University

Investigators

Study Director: Gökhan Metin, Professor, İstanbul Univesity, İstanbul Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadi Yavuz, Principal Investigator, Istanbul University

ClinicalTrials.gov Identifier:

NCT04437524

Other Study ID Numbers:

196481654

First Posted:

Jun 18, 2020

Last Update Posted:

Dec 9, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hadi Yavuz, Principal Investigator, Istanbul University

Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Syndrome

Study Results

No Results Posted as of Dec 9, 2020