The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients

NCT06791954 | Completed DMC

• 1 other identifier: 2024/5012
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; Pain; Telehealth; Telemedicine

Outcome Measures

Primary Outcomes (7)

• Ultrasonographic assessment

  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.

  First day (at beginning) and last day (8. weeks)

• McGill core endurance tests

  The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.

  First day (at beginning) and last day (8. weeks)

• Fibromyalgia Impact Questionnaire

  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.

  First day (at beginning) and last day (8. weeks)

• Fatigue Severity Scale

  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.

  First day (at beginning) and last day (8. weeks)

• Central Sensitization Inventory Short-Form

  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.

  First day (at beginning) and last day (8. weeks)

• Hospital Anxiety and Depression Scale

  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.

  First day (at beginning) and last day (8. weeks)

• Numeric Rating Scale

  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.

  First day (at beginning) and last day (8. weeks)

Study Arms (3)

Telerehabilitation group

ACTIVE COMPARATOR

Telerehabilitation group

Other: Exercise

Control group

OTHER

Control group

Other: Exercise

Healthy Control Group

NO INTERVENTION

The first results were compared

Interventions

Exercise OTHER

Clinical pilates program

Control group; Telerehabilitation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to cooperate with measurements
• Regular engagement in exercise

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 24, 2025
• Study Start: June 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: November 20, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)