Fibromyalgia SyndromeNCT04426864
Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.
A study testing Supervised Aerobic Plus Stretching Exercises, Supervised Resistance Plus Stretching Exercises Group and Home-based Stretching Exercises Group in people with Fibromyalgia Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Supervised Aerobic Plus Stretching Exercises, Supervised Resistance Plus Stretching Exercises Group and Home-based Stretching Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Jul 2020
- 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
- Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
- Participants were well communicative, motivated, and willing to participate in the study.
Who cannot join
- The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Medicine
Denizli, 20070
About this study
Official title: Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.
Read the detailed description
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.
Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).
Study Type: Interventional (Clinical Trial)
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Supervised Aerobic Plus Stretching Exercises, Supervised Resistance Plus Stretching Exercises Group, Home-based Stretching Exercises Group
- Keywords
- Fibromyalgia, Aerobic exercise, Resistance exercise, Stretching exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic Plus Stretching ExercisesOther
An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.
Supervised Resistance Plus Stretching Exercises GroupOther
According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.
Home-based Stretching Exercises GroupOther
Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Aerobic Plus Stretching Exercises Group | Active comparator | The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University. Receives: Other: Supervised Aerobic Plus Stretching Exercises |
| Supervised Resistance Plus Stretching Exercises Group | Experimental | The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University. Receives: Other: Supervised Resistance Plus Stretching Exercises Group |
| Home-based Stretching Exercises Group | Experimental | The participants were instructed to perform the stretching exercises at home. Receives: Other: Home-based Stretching Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in analogue scale (VAS) score at week 12
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Measured: Week 12
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Measured: Week 12
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Measured: Week 12
Change from baseline in Short Form 36 (SF-36) score at week 12.
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Measured: Week 12
Change from baseline in weight (kilograms) at week 12.
Weight was measured with body composition analyzer (Tanita MC580).
Measured: Week 12
Change from baseline in body mass index (BMI) at week 12
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Measured: Week 12
Change from baseline in total body fat percentage at week 12
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Measured: Week 12
Change from baseline in in total body muscle percentage at week 12.
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Measured: Week 12
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2019
- Primary completion1 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Participants are assigned to three groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Füsun Ardıç, Pamukkale University
- Investigators
- Fusun ARDIC, Prof.M.D., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426864
- Sponsor's protocol ID
- 2018TIPF044
- Status last verified
- Sep 2020
- First submitted
- 8 Jun 2020
- Last updated
- 16 Sep 2020
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.
- ClinicalTrials.gov ID
- NCT04426864
- Acronym / sponsor ID
- 2018TIPF044
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Aerobic exercise, Resistance exercise, Stretching exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Jun 2020 (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.
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.
Detailed description
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.
Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).
Study Type: Interventional (Clinical Trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to three groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Supervised Aerobic Plus Stretching Exercises Group | Active comparator | Other: Supervised Aerobic Plus Stretching ExercisesThe participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University. |
| Supervised Resistance Plus Stretching Exercises Group | Experimental | Other: Supervised Resistance Plus Stretching Exercises GroupThe participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University. |
| Home-based Stretching Exercises Group | Experimental | Other: Home-based Stretching Exercises GroupThe participants were instructed to perform the stretching exercises at home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
- Participants were well communicative, motivated, and willing to participate in the study.
Key exclusion criteria (1 listed)
- The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.
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 |
|---|---|---|
| Supervised Aerobic Plus Stretching ExercisesAn exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks. | Other | Supervised Aerobic Plus Stretching Exercises Group |
| Supervised Resistance Plus Stretching Exercises GroupAccording to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks. | Other | Supervised Resistance Plus Stretching Exercises Group |
| Home-based Stretching Exercises GroupEach exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance. | Other | Home-based Stretching Exercises Group |
Primary outcome
Change from baseline in analogue scale (VAS) score at week 12
Time frame: Week 12
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
Time frame: Week 12
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
Time frame: Week 12
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Change from baseline in Short Form 36 (SF-36) score at week 12.
Time frame: Week 12
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Change from baseline in weight (kilograms) at week 12.
Time frame: Week 12
Weight was measured with body composition analyzer (Tanita MC580).
Change from baseline in body mass index (BMI) at week 12
Time frame: Week 12
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Change from baseline in total body fat percentage at week 12
Time frame: Week 12
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in in total body muscle percentage at week 12.
Time frame: Week 12
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
Time frame: Week 12
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
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 16 Sep 2020.
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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.
Fusun ARDIC, Prof.M.D. study director
Pamukkale 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 Supervised Aerobic Plus Stretching Exercises, Supervised Resistance Plus Stretching Exercises Group and Home-based Stretching Exercises Group in people with Fibromyalgia Syndrome, run by Pamukkale 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 1 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 16 Sep 2020. 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?
Change from baseline in analogue scale (VAS) score at week 12 (time frame: Week 12). The study lists 9 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 16 Sep 2020.