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FibromyalgiaNCT05658432

Effects of Exercise Program Via Tele Rehabilitation on Patients With Fibromyalgia

A study testing Exercise via telehealth and Exercise unsupervised in people with Fibromyalgia, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Fibromyalgia
What is being tested?
Exercise via telehealth and Exercise unsupervised
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Dec 2022to 24 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University Faculty of Medicine

    Ankara, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Fibromyalgia
Being tested
Exercise via telehealth, Exercise unsupervised
Keywords
fibromyalgia, cardiopulmonary fitness, exercise, telehealth, telerehabilitation
Medical subject headings
Fibromyalgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise via telehealthOther

    Same as arm/group description

  • Exercise unsupervisedOther

    Same as arm/group description

Study groups in NCT05658432
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Other: Exercise via telehealth
Active controlActive comparatorControl 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.
Receives: Other: Exercise unsupervised

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 week, 8 week

Secondary outcomes (4)
  1. 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.

    Measured: 0 week, 8 week

  2. 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).

    Measured: 0 week, 8 week

  3. 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.

    Measured: 0 week, 8 week

  4. 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.

    Measured: 0 week, 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start17 Dec 2022
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, parallel assignment, superiority, controlled trial
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658432
Sponsor's protocol ID
2407
Status last verified
Apr 2025
First submitted
12 Dec 2022
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise via telehealth and Exercise unsupervised in people with Fibromyalgia, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain (time frame: 0 week, 8 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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