Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05658432

Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia

Conditions: Fibromyalgia

Sex: Female
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 60
Sponsor: Ankara University

Location: Turkey

Summary

This study is a randomized, parallel, superiority, controlled trial. The main objective 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. Participants will be women with fibromyalgia, 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 exercise program of 8 weeks. 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.

Eligibility Criteria

Inclusion Criteria:diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criterianot attended in any exercise program in the last 3 monthswritten consent to participate in the study regardless of the allocation groupeligibility for digital literacyExclusion Criteria:pregnancy or breastfeeding patientsabsolute or relative contraindications for exercise including cardiopulmonary, uncontrolled systemic and/or musculoskeletal conditionspsychiatric or cognitive disorder that may hamper assessments and treatmentlack of internet access

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05658432). StuddyBuddy aggregates publicly available trial information.