FibromyalgiaNCT06243562
The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia
A study testing combined exercises and progressive muscle relaxation group and combined exercises group in people with Fibromyalgia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- combined exercises and progressive muscle relaxation group and combined exercises group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 15 Feb 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with fibromyalgia over the age of 20
- volunteering to participate in the study.
Who cannot join
- neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
- serious psychiatric illness (schizophrenia, etc.)
- any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
- Malignancy
- pregnancy
- menopause
- Participating in a physical therapy program (receiving exercise / relaxation training) in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu, Merkez, 14030
Eylem TÜTÜN YÜMİN, Professor, +905056763191, eylemtutun78@hotmail.com
About this study
Official title: The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia
The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.
Read the detailed description
Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance
The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.
There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.
Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.
Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.
- Conditions
- Fibromyalgia
- Being tested
- combined exercises and progressive muscle relaxation group, combined exercises group
- Keywords
- fibromyalgia, progressive muscle relaxation, combined exercise, rehabilitation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined exercises and progressive muscle relaxation groupOther
Participants in the intervention group will receive a combined exercise program that will last 45-60 minutes, 3 days a week for 8 weeks, and progressive muscle relaxation training that will last 10-15 minutes, under the supervision of a therapist.
combined exercises groupOther
Patients in the control group will perform a combined exercise consisting of aerobic, strengthening and stretching exercises, which will last 45-60 minutes, 3 days a week for 8 weeks, under the supervision of a physiotherapist. At the end of the combined exercise program, they will rest in the relaxation position for 10-15 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| combined exercises and progressive muscle relaxation group | Active comparator | Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise, as well as progressive muscle relaxation training. The studies will be carried out under the supervision of a physiotherapist. Receives: Other: combined exercises and progressive muscle relaxation group |
| combined exercises group | Active comparator | Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise. They will rest for 10-15 minutes in a relaxation position only. The studies will be carried out under the supervision of a physiotherapist. Receives: Other: combined exercises group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale measures pain intensity. It consists of a 10 cm line with two end points representing 0 (no pain) to 10 (pain as bad as possible). The patient marks the current pain level by placing a mark on the line.
Measured: Eight weeks
The Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a self-report measure of pain-related catastrophizing thinking. It consists of 13 items on a five-point Likert scale (0 = never to 4 = always ). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.
Measured: Eight weeks
Secondary outcomes (13)
The Fibromyalgia Impact Scale
The Fibromyalgia Impact Scale assesses the severity of fibromyalgia and its impact on daily function. It contains 10 items: subscores are summed to create a scale from 0 to 100, with a higher score indicating worse symptoms and greater dysfunction.
Measured: Eight weeks
COMPASS 31 Scale:
COMPASS 31 scale is a self-assessment tool that investigates autonomic symptoms. The scale contains 31 items assessing six domains of autonomic functions. The total score ranges from 0 (normal) to 100 (worst case).
Measured: Eight weeks
Skin Temperature
Peripheral skin temperature will be measured from the medial longitudinal arch with a thermometer.
Local skin temperature will be measured with a thermometer from : Right and left lower costal margins, the highest point of the iliac crest (superior side) and the posterior superior iliac spine (inferior side).
Measured: Eight weeks
Pulse
Pulse will be measured with a pulse oximeter attached to the fingertip.
Measured: Eight weeks
Saturation
Saturation will be measured with a pulse oximeter attached to the fingertip.
Measured: Eight weeks
Blood Pressure
The patients' blood pressure will be measured with a sphygmomanometer
Measured: Eight weeks
The Respiratory Frequency
The respiratory frequency value will be obtained by multiplying the number of breaths in and out for thirty seconds by two.
Measured: Eight weeks
Sit and Reach Test
Flexibility will be evaluated with the sit and reach test. Subjects will be asked to sit on the floor to be tested and place their bare feet flat on the test stand. The subject will be asked to lean forward from the body and will extend his/her hands in front of his body as far forward as he can without bending his knees. The farthest point shown by the fingertip will be measured with the help of a tape measure.
Measured: Eight weeks
Grip Strength
Grip Strength is evaluates the strength of the hand muscles used to grasp. In the test procedure, three measurements are made for hand grip strength,and the averages are recorded separately for right and left.
Measured: Eight weeks
Pittsburgh Sleep Quality Index
Pittsburgh sleep quality index, consists of 19 items grouped according to seven component scores. Scores on the seven components are then summed to give a global Pittburgh Sleep Quality İndex score ranging from 0 to 21. Scores between 0 and 4 indicate good sleep quality, scores between 5 and 10 indicate poor quality, and above 10 indicate sleep disturbance.
Measured: Eight weeks
6-Minute Walk Test
The 6-minute walk test measures the maximum distance in meters that a person can walk as fast as possible over a 6-minute period.
Measured: Eight weeks
Perceived Stress Scale
Perceived stress scale, is a 10-item that assesses the amount of perceived psychological stress during the past month. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". A high score indicates a person's perception of stress is high
Measured: eight weeks
The Fatigue Severity Scale
The fatigue severity scale, evaluates how fatigue affects motivation, exercise, physical functioning, performance of tasks, work, family and social life. It is scored on a 7-point Likert scale. A total score is 9-63 , and a score of 36 and above indicates severe fatigue.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion12 Apr 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
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 Abant Izzet Baysal 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
- There will be an intervention and control group in the study.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem TÜTÜN YÜMİN, Abant Izzet Baysal University
- Investigators
- Eylem TÜTÜN YÜMİN, Professor, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243562
- Sponsor's protocol ID
- AIBU-FTR-ETY-03
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06243562
- Acronym / sponsor ID
- AIBU-FTR-ETY-03
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, progressive muscle relaxation, combined exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 12 Apr 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 6 Feb 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.
The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.
Detailed description
Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance
The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.
There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.
Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.
Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be an intervention and control group in the study.
| Arm | Type | Receives |
|---|---|---|
| combined exercises and progressive muscle relaxation group | Active comparator | Other: combined exercises and progressive muscle relaxation groupParticipants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise, as well as progressive muscle relaxation training. The studies will be carried out under the supervision of a physiotherapist. |
| combined exercises group | Active comparator | Other: combined exercises groupParticipants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise. They will rest for 10-15 minutes in a relaxation position only. The studies will be carried out under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women diagnosed with fibromyalgia over the age of 20
- volunteering to participate in the study.
Key exclusion criteria (7 listed)
- neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
- serious psychiatric illness (schizophrenia, etc.)
- any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
- Malignancy
- pregnancy
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 |
|---|---|---|
| combined exercises and progressive muscle relaxation groupParticipants in the intervention group will receive a combined exercise program that will last 45-60 minutes, 3 days a week for 8 weeks, and progressive muscle relaxation training that will last 10-15 minutes, under the supervision of a therapist. | Other | combined exercises and progressive muscle relaxation group |
| combined exercises groupPatients in the control group will perform a combined exercise consisting of aerobic, strengthening and stretching exercises, which will last 45-60 minutes, 3 days a week for 8 weeks, under the supervision of a physiotherapist. At the end of the combined exercise program, they will rest in the relaxation position for 10-15 minutes each session. | Other | combined exercises group |
Primary outcome
Visual Analog Scale
Time frame: Eight weeks
The Visual Analog Scale measures pain intensity. It consists of a 10 cm line with two end points representing 0 (no pain) to 10 (pain as bad as possible). The patient marks the current pain level by placing a mark on the line.
The Pain Catastrophizing Scale
Time frame: Eight weeks
The Pain Catastrophizing Scale is a self-report measure of pain-related catastrophizing thinking. It consists of 13 items on a five-point Likert scale (0 = never to 4 = always ). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.
13 secondary outcomes
The Fibromyalgia Impact Scale
Time frame: Eight weeks
COMPASS 31 Scale:
Time frame: Eight weeks
Skin Temperature
Time frame: Eight weeks
Pulse
Time frame: Eight weeks
Saturation
Time frame: Eight weeks
Blood Pressure
Time frame: Eight weeks
The Respiratory Frequency
Time frame: Eight weeks
Sit and Reach Test
Time frame: Eight weeks
Grip Strength
Time frame: Eight weeks
Pittsburgh Sleep Quality Index
Time frame: Eight weeks
6-Minute Walk Test
Time frame: Eight weeks
Perceived Stress Scale
Time frame: eight weeks
The Fatigue Severity Scale
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Eylem TÜTÜN YÜMİN, Professor study director
Abant Izzet Baysal 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 combined exercises and progressive muscle relaxation group and combined exercises group in people with Fibromyalgia, run by Abant Izzet Baysal 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 15 Feb 2024.