Clinical trial NCT06277596: The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia
Official title: Comparison of the Effects of Progressive Clinical Pilates Exercises Applied as a Supervised and Home Program in Individuals With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Exercise
chronic pain
clinical pilates
Functional
Psychosocial
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Visual Analog Scale ( VAS )
timeFrame: 6 weeks
Secondary outcomes:
measure: Sociodemographic information (age)
timeFrame: 6 weeks
measure: Sociodemographic information (height)
timeFrame: 6 weeks
measure: Sociodemographic information (weight)
timeFrame: 6 weeks
measure: Trunk Muscle Endurance (McGill Endurance Test and Plank Test)
timeFrame: 6 weeks
measure: Chair Sit to stand test
timeFrame: 6 weeks
measure: 6 minute walk test
timeFrame: 6 weeks
measure: Fatigue Severity Scale
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 weeks
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: 6 weeks
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: 6 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: 6 weeks
measure: Body Awareness Questionnaire
timeFrame: 6 weeks
measure: Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ)
timeFrame: 6 weeks
measure: Short form-36 (SF-36)
timeFrame: 6 weeks
measure: Treatment Satisfaction Evaluation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Ebru Kadıoğlu, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Sevim Oksuz, Asst.Prof.Dr
role: STUDY_DIRECTOR
References: