Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437524
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hadi Yavuz, Istanbul University

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 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).
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 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.

  2. Pain (Visual Analogue Scale) [ Time Frame: 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.

  3. Muscle Strength Evaluation [ Time Frame: 6 weeks ]
    The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female fibromyalgia patients will be admitted to the study.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437524


Locations
Layout table for location information
Turkey
İstanbul Faculty of Medicine, Department of Sports Medicine
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Study Director: Gökhan Metin, Professor İstanbul Univesity, İstanbul Faculty of Medicine
Layout table for additonal information
Responsible Party: Hadi Yavuz, Sport Medicine Department, Istanbul University
ClinicalTrials.gov Identifier: NCT04437524    
Other Study ID Numbers: 196481654
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadi Yavuz, Istanbul University:
Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases