FibromyalgiaNCT06299527
Telerehabilitation in Patients With Fibromyalgia
A study testing Exercise Program in people with Fibromyalgia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2023to 27 Jan 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
- Having independent mobility,
- Not having advanced vision and hearing loss,
- Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access
Who cannot join
- Have a rheumatic disease with more prominent symptoms than FMS,
- Have an active infection,
- Have a surgical operation in the last three months,
- Have an uncontrollable chronic disease,
- Have another musculoskeletal disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences
Istanbul, Maltepe, 1464185881
About this study
Official title: Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study
Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
Read the detailed description
Materials and methods: A randomized clinical study. Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
- Conditions
- Fibromyalgia
- Being tested
- Exercise Program
- Keywords
- Fibromyalgia, Telerehabilitation, Mobile health
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
Exercise Program In our study, the telerehabilitation program was applied for both synchronous and asynchronous groups, 3 days a week, 1 session per day, for 8 weeks. The exercises were combined individually according to the person's capacity, and the intensity and duration of the exercise will gradually increase according to the patient's tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Exercise Group | Experimental | Synchronous telerehabilitation was performed via videoconference. Patients were taken to video conference calls accompanied by a researcher and supervisor. Participants were to perform their exercises simultaneously under the guidance of the researcher. Participants were taken to video conference calls in groups of 5 with similar functional levels. Each session lasts an average of 45 minutes. It was last. The start and end date of the exercise program, the number of repetitions for each exercise, the number of sets, daily repetitions, rest time between sets and the order of the exercises were determined by the researcher. Receives: Other: Exercise Program |
| Asynchronous Exercise Group | Active comparator | Asynchronous telerehabilitation was carried out through the mobile application. Researchers created a record for each participant in the mobile application with the personal information of the participants. Participants were logged in to the application with an account address and password created for them. The mobile application was supervised and followed by a researcher. The principal researcher prepared an exercise program specifically for each participant. He sent the exercise program he had prepared to the relevant participants through the application. In the mobile application, all exercises are explained in video and writing. Receives: Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A visual analog scale was used to evaluate the patient's pain. This scale is used to quantify pain intensity that cannot be measured numerically. Numbers are written on the two ends of a 10 cm line. The patient is asked to indicate on this line where the pain condition is appropriate during rest by drawing a line, putting a dot or pointing. For pain intensity, according to the scale, "no pain" will be rated as 0 points and "worst pain imaginable" as 10 points. The ranges for pain intensity were determined as <3 Mild pain, 3-6 moderate pain, 6 and above severe pain.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Secondary outcomes (7)
Revised Fibromyalgia Impact Questionnaire
The Revised Fibromyalgia Impact Questionnaire was used to assess limitations and functional disability in patients with fibromyalgia. The patient was asked to complete the questionnaire consisting of three sections and 21 questions. This scale measures 10 characteristics: physical function, well-being, inability to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. All questions are assessed on a numeric scale of 0-10.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) was used to assess the extent of patients' destructive thoughts and feelings associated with the sensation of pain. It is a 13-item questionnaire to be completed by the patient. It consists of three subscales: helplessness, exaggerated perception and rumination. Each item is scored on a 5-point scale, with higher values indicating greater destructiveness. The sum of the corresponding items gives scores for the subscales; the total score is calculated by summing all items. AFC scores range from 0 to 52 points.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HAD) was used to determine the anxiety and depression status of the patients. It includes anxiety and depression subscales. The scale is a self-report scale and consists of a total of 14 items, 7 of which investigate symptoms of depression and 7 of which investigate symptoms of anxiety. Responses are evaluated on a four-point Likert scale and scored on a 0-3 scale. In preparing the scoring, 0-1 will be considered as not ill, 2 as borderline ill, and 3-4 as significantly ill.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
6 Minute Walk Test
The 6-minute walk test (6MWD) was used to measure the functional capacity of the patients. 6MWD is a submaximal, indirect cardiovascular physical fitness test. It was developed by Balke in 1963 to measure functional capacity. The test will be performed on a 30 m-long flat walking track with a marked start and end point. On this track, the participant should walk for 6 minutes, making rounds and turns. There should not be any obstacles or crowds on the track. The ground should be flat and hard. The participant determines the walking speed himself/herself. He/she performs the test at the most suitable speed for him/her. The patient can rest during that time. The stopwatch was not stopped during the rest period; the participant's rest will be noted, and the rest period will be recorded. If test termination criteria are met, the test will be terminated. Emergency intervention was applied if necessary.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Arm Curl Test
The Arm curl test was used to assess the upper trunk functional strength of the patients. A straight-back chair without armrests, a stopwatch and a small hand barbell were used. The patient sits slightly on the edge of the chair towards the side of the arm to be tested and completes the test by making full lifts for 30 seconds with the arm in full extension below and full flexion above. The test starts with the patient's arm in extension and perpendicular to the floor. Before starting the test, the patient is shown and explained how the test will be performed and is made to try 2-3 times without giving the weights. After ensuring that the patient understands how to perform the test, the test is started, and the number of full weight lifts during 30 seconds constitutes the patient's score
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Laser Cursor Assisted Angle Repetition Test (LI-RATT)
The Laser Cursor Assisted Angle Repetition test was used to evaluate the cervical joint position sense of the patients. With this test, joint position sense, which is a part of proprioception and provides information about the speed and direction of active and passive movements of individuals without visual stimulation, will be measured. The protocol described by Revel et al. was used to apply the test. Patients were positioned 90 cm between the target table, which is 90x80 cm, and the person. The laser pointer was placed around the head with the help of a suitable tape in the center of the forehead of the individual. The patient's head was positioned so the laser pointer pointed vertically to the center of the target table.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Short Form - 12
Short Form - 12 was used to assess patients' HrQoL. The Short Form-36 was developed by Ware et al. to assess HrQoL. This scale, comprising thirty-six items, addresses the dimensions of physical functioning, role limitation due to physical problems, pain, social functioning, mental health, role limitation due to emotional state, energy and a general understanding of health. The subscales assess health between 0 and 100. Similar to the Short Form-36, the Short Form-12 consists of 8 subscales and 12 items, including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). Each sub-dimension of each scale is calculated with the help of a formula, and the scores are between 0 and 100.
Measured: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start27 May 2023
- Primary completion15 Nov 2023
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Timurtas, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299527
- Sponsor's protocol ID
- 01032024
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.
PubMed 14131272Soylu C, Kütük B. "Reliability and validity study of the Turkish form of the SF-12 Quality of Life Scale." Turkish Journal of Psychiatry.2020; 1-9.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995; 7(4): 524.
Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
PubMed 19664287Timurtas E, Huzmeli I, Demirbuken I, Polat MG. Clinical outcomes of asynchronous telerehabilitation through a mobile app are equivalent to synchronous telerehabilitation in patients with fibromyalgia: a randomized control study. BMC Musculoskelet Disord. 2025 Feb 4;26(1):118. doi: 10.1186/s12891-025-08377-6.
PubMed 39905353
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT06299527
- Acronym / sponsor ID
- 01032024
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Telerehabilitation, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 8 Mar 2024 (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.
Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
Detailed description
Materials and methods: A randomized clinical study. Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchronous Exercise Group | Experimental | Other: Exercise ProgramSynchronous telerehabilitation was performed via videoconference. Patients were taken to video conference calls accompanied by a researcher and supervisor. Participants were to perform their exercises simultaneously under the guidance of the researcher. Participants were taken to video conference calls in groups of 5 with similar functional levels. Each session lasts an average of 45 minutes. It was last. The start and end date of the exercise program, the number of repetitions for each exercise, the number of sets, daily repetitions, rest time between sets and the order of the exercises were determined by the researcher. |
| Asynchronous Exercise Group | Active comparator | Other: Exercise ProgramAsynchronous telerehabilitation was carried out through the mobile application. Researchers created a record for each participant in the mobile application with the personal information of the participants. Participants were logged in to the application with an account address and password created for them. The mobile application was supervised and followed by a researcher. The principal researcher prepared an exercise program specifically for each participant. He sent the exercise program he had prepared to the relevant participants through the application. In the mobile application, all exercises are explained in video and writing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
- Having independent mobility,
- Not having advanced vision and hearing loss,
- Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access
Key exclusion criteria (5 listed)
- Have a rheumatic disease with more prominent symptoms than FMS,
- Have an active infection,
- Have a surgical operation in the last three months,
- Have an uncontrollable chronic disease,
- Have another musculoskeletal disorder
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 ProgramExercise Program In our study, the telerehabilitation program was applied for both synchronous and asynchronous groups, 3 days a week, 1 session per day, for 8 weeks. The exercises were combined individually according to the person's capacity, and the intensity and duration of the exercise will gradually increase according to the patient's tolerance. | Other | Asynchronous Exercise Group, Synchronous Exercise Group |
Primary outcome
Visual Analog Scale
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
A visual analog scale was used to evaluate the patient's pain. This scale is used to quantify pain intensity that cannot be measured numerically. Numbers are written on the two ends of a 10 cm line. The patient is asked to indicate on this line where the pain condition is appropriate during rest by drawing a line, putting a dot or pointing. For pain intensity, according to the scale, "no pain" will be rated as 0 points and "worst pain imaginable" as 10 points. The ranges for pain intensity were determined as <3 Mild pain, 3-6 moderate pain, 6 and above severe pain.
7 secondary outcomes
Revised Fibromyalgia Impact Questionnaire
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Pain Catastrophizing Scale
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Hospital Anxiety and Depression Scale
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
6 Minute Walk Test
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Arm Curl Test
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Laser Cursor Assisted Angle Repetition Test (LI-RATT)
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Short Form - 12
Time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
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 13 Mar 2024.
- Background: PubMed 14131272BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.
- BackgroundSoylu C, Kütük B. "Reliability and validity study of the Turkish form of the SF-12 Quality of Life Scale." Turkish Journal of Psychiatry.2020; 1-9.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- BackgroundSullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995; 7(4): 524.
- Background: PubMed 19664287Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
- Derived from this study: PubMed 39905353Timurtas E, Huzmeli I, Demirbuken I, Polat MG. Clinical outcomes of asynchronous telerehabilitation through a mobile app are equivalent to synchronous telerehabilitation in patients with fibromyalgia: a randomized control study. BMC Musculoskelet Disord. 2025 Feb 4;26(1):118. doi: 10.1186/s12891-025-08377-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Program in people with Fibromyalgia, run by Marmara 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 5 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 13 Mar 2024. 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?
Visual Analog Scale (time frame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299527, which also lists 6 linked publications.
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 13 Mar 2024.