Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia

NCT05658432 | Completed

• 1 other identifier: 2407
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to investigate the effects of a telehealth exercise program on pain, symptoms, and cardiopulmonary fitness level of patients with fibromyalgia compared to a home exercise program. The main questions aims to answer:

• Is telehealth exercise program is superior to unsupervised home exercise program in and increasing cardiopulmonary fitness level?
• Is telehealth exercise program is superior to unsupervised home exercise program in controlling symptoms? Women participants with fibromyalgia randomized to an intervention or comparison group. Intervention group will exercise via telehealth system under supervision. Comparison group will exercise alone at home. Researchers will compare the effects of supervised telehealth exercise program and home exercise on pain, symptoms, and cardiopulmonary fitness level of patients with fibromyalgia.

Conditions

Fibromyalgia

Keywords

fibromyalgia; cardiopulmonary fitness; exercise; telehealth; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes in Pain

  Visual Analogue Scale (VAS) for pain will be used to measure the amplitude of patients' pain with fibromyalgia which is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. A straight horizontal line of 100 mm will be used, of which the ends are defined as the extreme limits of pain orientated from the left (worst) to the right (best). 20 mm decrease in VAS pain is considered to be an clinically important improvement.

  0 week, 8 week

Secondary Outcomes (4)

• Impact of fibromyalgia on daily activities

  0 week, 8 week

• Symptoms related to psychological status

  0 week, 8 week

• Physical activity level

  0 week, 8 week

• Functional physical capacity

  0 week, 8 week

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group will perform an exercise program including aerobic, range of motion, stretching exercises on zoom sessions of 45 minutes each, under the supervision of the investigator, following a prerecorded exercise video. They will exercise thrice a week for 8 weeks, in groups of five.

Other: Exercise via telehealth

Active control

ACTIVE COMPARATOR

Control group will have access to the same exercise video and guided for the first session. They will be asked to do the exercises at home, exact the same duration and frequency of the experimental group but without supervision, for 8 weeks.

Other: Exercise unsupervised

Interventions

Exercise via telehealth OTHER

Same as arm/group description

Intervention

Exercise unsupervised OTHER

Same as arm/group description

Active control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria
• not attended in any exercise program in the last 3 months
• written consent to participate in the study regardless of the allocation group
• eligibility for digital literacy

You may not qualify if:

• pregnancy or breastfeeding patients
• absolute or relative contraindications for exercise including cardiopulmonary, uncontrolled systemic and/or musculoskeletal conditions
• psychiatric or cognitive disorder that may hamper assessments and treatment
• lack of internet access

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Yesim Kurtais Aytur, Prof., MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, parallel assignment, superiority, controlled trial

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: December 17, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

TU (1)