Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia

The Effect of Exercise Program Via Tele Rehabilitation on the Disease Symptoms and Cardiopulmonary Fitness Level in Patients With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Exercise via telehealth; Other: Exercise unsupervised

Detailed Description

This study is a randomized, parallel, superiority, controlled trial. Participants will be female patients with fibromyalgia who are admitted to Fibromyalgia Out-patient Clinic of Ankara University, Faculty of Medicine, Physical Medicine and Rehabillitation Department. Eligible patients will be randomized to be allocated to one of the two groups, experiment or control. Both groups will be informed about the possible positive effects of exercise. 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. 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. The control group will be called first once a week, than once in two weeks to remind exercising and fill out their exercise diary. All patients will be assessed by VAS for pain, Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), cardiopulmonary exercise test and 6 min. walking test (6MWT) before and at the end of 8-weeks exercise program. Other symptoms related to fibromyalgia such as fatigue, sleep etc will also be recorded. Primary outcome measure is pain. Secondary outcome measures will be cardiopulmonary fitness level (VO2max), functional physical activity level (6MWT), symptom severity, disease impact (FIQ), psychological status (HADS) and subjective assessment of general well-being. The study's hypothesis suggest that improvement will be superior in the experimental group without any side effects.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Ankara University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Same as arm/group description
Active Comparator: Active control; 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; Same as arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of fibromyalgia on daily activities	Fibromyalgia Impact Questionnaire (FIQ) is an instrument developed to assess the current health status of women with the fibromyalgia syndrome in clinical and research settings. Survey evaluates the severity of the condition on the individual's functional capacity and the quality of life. Each item is scored 0 to 10 and the total scores range from 0 to 100, where higher values indicate more disease impact. Scores are expressed as follows: from 0 to 38 mild effect, from 39 to 58 moderate effect, and from 59 to 100 severe impact. FIQ and validated in 1991 by Burckhardt et al., revised by Bennett RM, et al, in 2009. Revised FIQ was translated and adapted for the Turkish version in 2010 by Ediz, et al.	0 week, 8 week
Symptoms related to psychological status	Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Zigmond and Snaith created this outcome measure specifically to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. So; it was created as a tool for the detection of anxiety and depression in people with physical health problems. Turkish validation and reliability study was done by Aydemir, et al (1997).	0 week, 8 week
Physical activity level	Physical activity will be assessed by VO2max which is the gold standard and will be directly measured by cardiopulmonary exercise testing (CPET). Before CPET dynamic lung function will be measured, and the exercise test will be performed by using Modified Bruce protocol on treadmill until the maximal exertion. During exercise testing ACSM's standards and guidelines (2021) will be followed. Standard CPET parameters such as oxygen consumption at anaerobic threshold, respiratory exchange ratio, respiratory quotient, and metabolic equivalent of task (MET) VO2-AT, RER, RQ, MET will also be recorded besides VO2max.	0 week, 8 week
Functional physical capacity	Functional capacity will be assessed by 6 minute walking test (6MWT) which was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. It is a sub-maximal exercise test used to assess endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation. The validity and reliability of the test in fibromyalgia was shown by King, et al 1999, Pankoff, at al 2000.	0 week, 8 week

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Yesim Kurtais Aytur, Prof., MD, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2022
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: exercise; fibromyalgia; telerehabilitation; telehealth; cardiopulmonary fitness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No