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).
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
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Exercise via telehealth |
| Active control | Active comparator | 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. Receives: Other: Exercise unsupervised |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted20 Dec 2022
- Study start17 Dec 2022
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeşim Kurtaiş Aytür, MD, Ankara University
- Investigators
- Yesim Kurtais Aytur, Prof., MD, Principal investigator, Ankara University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Program Via Tele Rehabilitation on the Disease Symptoms and Cardiopulmonary Fitness Level in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05658432
- Acronym / sponsor ID
- 2407
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, cardiopulmonary fitness, exercise, telehealth, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel assignment, superiority, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise via telehealthThe 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. |
| Active control | Active comparator | Other: Exercise unsupervisedControl 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise via telehealthSame as arm/group description | Other | Intervention |
| Exercise unsupervisedSame as arm/group description | Other | Active control |
Primary outcome
Changes in Pain
Time frame: 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.
4 secondary outcomes
Impact of fibromyalgia on daily activities
Time frame: 0 week, 8 week
Symptoms related to psychological status
Time frame: 0 week, 8 week
Physical activity level
Time frame: 0 week, 8 week
Functional physical capacity
Time frame: 0 week, 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yesim Kurtais Aytur, Prof., MD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
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.