Clinical trial NCT05658432: Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia
Official title: The Effect of Exercise Program Via Tele Rehabilitation on the Disease Symptoms and Cardiopulmonary Fitness Level in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
cardiopulmonary fitness
exercise
telehealth
telerehabilitation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel assignment, superiority, controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pain
timeFrame: 0 week, 8 week
Secondary outcomes:
measure: Impact of fibromyalgia on daily activities
timeFrame: 0 week, 8 week
measure: Symptoms related to psychological status
timeFrame: 0 week, 8 week
measure: Physical activity level
timeFrame: 0 week, 8 week
measure: Functional physical capacity
timeFrame: 0 week, 8 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
Study officials:
affiliation: Ankara University
name: Yesim Kurtais Aytur, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: