Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia

Sponsor

Ankara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05658432

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Other: Exercise via telehealth Other: Exercise unsupervised	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, parallel assignment, superiority, controlled trialRandomized, parallel assignment, superiority, controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in Pain [0 week, 8 week]
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.

Secondary Outcome Measures

Impact of fibromyalgia on daily activities [0 week, 8 week]
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.
Symptoms related to psychological status [0 week, 8 week]
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).
Physical activity level [0 week, 8 week]
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.
Functional physical capacity [0 week, 8 week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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