Working…
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 : Completed
First Posted : June 18, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hadi Yavuz, Istanbul University

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date December 9, 2020
Actual Study Start Date  ICMJE August 24, 2020
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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.
  • 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.
  • Muscle Strength Evaluation [ Time Frame: 6 weeks ]
    The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.
Official Title  ICMJE Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia Syndrome
Intervention  ICMJE Other: therapeutic exercises
Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
Study Arms  ICMJE
  • Active Comparator: balance-proprioception exercises group
    balance-proprioception exercises group
    Intervention: Other: therapeutic exercises
  • Active Comparator: aerobic exercises group
    aerobic exercises group
    Intervention: Other: therapeutic exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2020)
51
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)
62
Actual Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female fibromyalgia patients will be admitted to the study.
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04437524
Other Study ID Numbers  ICMJE 196481654
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadi Yavuz, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gökhan Metin, Professor İstanbul Univesity, İstanbul Faculty of Medicine
PRS Account Istanbul University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP