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Clinical Trials/NCT06277596
NCT06277596
Recruiting
Not Applicable

Comparison of the Effects of Progressive Clinical Pilates Exercises Applied as a Supervised and Home Program in Individuals With Fibromyalgia

Eastern Mediterranean University1 site in 1 country48 target enrollmentApril 10, 2024
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Eastern Mediterranean University
Enrollment
48
Locations
1
Primary Endpoint
Visual Analog Scale ( VAS )
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50.

Detailed Description

After the voluntary individuals with Fibromyalgia (FM) who meet the inclusion criteria are evaluated, they will be randomly divided into two groups: exercise group and home exercise group. The same clinical Pilates program will be applied to both groups at the same dosage. Evaluations and treatment will be applied to both groups by the same physiotherapist. Individuals will perform the exercises 10 repetitions, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. For the home exercise group, all exercises will be shown and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking.

Registry
clinicaltrials.gov
Start Date
April 10, 2024
End Date
August 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Volunteer individuals between the ages of 20-50
  • Diagnosed with fibromyalgia according to the American College of Rheumatology criteria
  • Pain level 3 and above according to visual analogue scale.
  • Individuals who are sedentary (who have not engaged in physical activity at least 3 days a week in the last 3 months) will be included in the study.

Exclusion Criteria

  • Having additional rheumatic disease
  • Using NSAIDs and antidepressant drugs
  • Individuals with orthopedic, neurological and cardiopulmonary diseases that prevent them from exercising
  • Pregnant women
  • Malignancy
  • Individuals with uncontrolled systemic diseases (diabetes, systemic arterial hypertension, thyroid dysfunction, neurological, cardiorespiratory, musculoskeletal problems, etc.)

Outcomes

Primary Outcomes

Visual Analog Scale ( VAS )

Time Frame: 6 weeks

Pain during activities of daily living and at rest will be evaluated with the Visual Analogue Scale (VAS). The individual will be asked to mark the appropriate point on a 10-centimeter (cm) horizontal line between 0 (no pain) and 10 (unbearable pain) at both ends. The distance between the point marked by the individual and the start will be measured with a ruler in cm and recorded. A 2-point reduction in VAS is considered a clinically important improvement.

Secondary Outcomes

  • Fear-Avoidance Beliefs Questionnaire(6 weeks)
  • Pain Self-Efficacy Questionnaire(6 weeks)
  • Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ)(6 weeks)
  • Sociodemographic information (weight)(6 weeks)
  • Pittsburgh Sleep Quality Index(6 weeks)
  • Treatment Satisfaction Evaluation(6 weeks)
  • Chair Sit to stand test(6 weeks)
  • Fatigue Severity Scale(6 weeks)
  • Sociodemographic information (age)(6 weeks)
  • Sociodemographic information (height)(6 weeks)
  • Trunk Muscle Endurance (McGill Endurance Test and Plank Test)(6 weeks)
  • 6 minute walk test(6 weeks)
  • Revised Fibromyalgia Impact Questionnaire(6 weeks)
  • Body Awareness Questionnaire(6 weeks)
  • Short form-36 (SF-36)(6 weeks)

Study Sites (1)

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