The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients

Not Applicable

Completed

• Conditions: Fibromyalgia Syndrome

• Registration Number: NCT06791954
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-15
• Primary Completion: 2024-08-15
• Study Completion: 2024-11-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis of FMS at least one year before the study
• Stable general health condition for the past 6 months

Exclusion Criteria

• Inability to cooperate with measurements
• Regular engagement in exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ultrasonographic assessment	First day (at beginning) and last day (8. weeks)	A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.
McGill core endurance tests	First day (at beginning) and last day (8. weeks)	The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.
Fatigue Severity Scale	First day (at beginning) and last day (8. weeks)	Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.
Fibromyalgia Impact Questionnaire	First day (at beginning) and last day (8. weeks)	The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.
Central Sensitization Inventory Short-Form	First day (at beginning) and last day (8. weeks)	Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.
Hospital Anxiety and Depression Scale	First day (at beginning) and last day (8. weeks)	The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.
Numeric Rating Scale	First day (at beginning) and last day (8. weeks)	The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey