FibromyalgiaNCT06277596
The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia
A study testing Exercise in people with Fibromyalgia, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Apr 2024to 30 Aug 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer individuals between the ages of 20-50
- Diagnosed with fibromyalgia according to the American College of Rheumatology criteria
- Pain level 3 and above according to visual analogue scale.
- Individuals who are sedentary (who have not engaged in physical activity at least 3 days a week in the last 3 months) will be included in the study.
Who cannot join
- Having additional rheumatic disease
- Using NSAIDs and antidepressant drugs
- Individuals with orthopedic, neurological and cardiopulmonary diseases that prevent them from exercising
- Pregnant women
- Malignancy
- Individuals with uncontrolled systemic diseases (diabetes, systemic arterial hypertension, thyroid dysfunction, neurological, cardiorespiratory, musculoskeletal problems, etc.)
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta, 99628
Sevim Oksüz, Asst.Prof.Dr, 5488351465 ext. +90, sevim.oksuz@emu.edu.tr
About this study
Official title: Comparison of the Effects of Progressive Clinical Pilates Exercises Applied as a Supervised and Home Program in Individuals With Fibromyalgia
The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50.
Read the detailed description
After the voluntary individuals with Fibromyalgia (FM) who meet the inclusion criteria are evaluated, they will be randomly divided into two groups: exercise group and home exercise group.
The same clinical Pilates program will be applied to both groups at the same dosage. Evaluations and treatment will be applied to both groups by the same physiotherapist. Individuals will perform the exercises 10 repetitions, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. For the home exercise group, all exercises will be shown and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking.
- Conditions
- Fibromyalgia
- Being tested
- Exercise
- Keywords
- Exercise, chronic pain, clinical pilates, Functional, Psychosocial
- Medical subject headings
- Fibromyalgia, Motor Activity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Clinical Pilates exercises (basic and advanced stabilization exercises)
| Study group | Role | What they receive |
|---|---|---|
| Supervise clinical Pilates group | Experimental | Clinical Pilates exercises will be performed 10 repetitions, 3 days a week, for 6 weeks, under the supervision of a physiotherapist. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. Receives: Other: Exercise |
| Clinical Pilates as home exercise | Active comparator | The same exercises will be shown to the home exercise group and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking. In the 3rd week, new exercises will be shown to individuals. It will be applied 10 times, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale ( VAS )
Pain during activities of daily living and at rest will be evaluated with the Visual Analogue Scale (VAS). The individual will be asked to mark the appropriate point on a 10-centimeter (cm) horizontal line between 0 (no pain) and 10 (unbearable pain) at both ends. The distance between the point marked by the individual and the start will be measured with a ruler in cm and recorded. A 2-point reduction in VAS is considered a clinically important improvement.
Measured: 6 weeks
Secondary outcomes (15)
Sociodemographic information (age)
Age will be recorded as years
Measured: 6 weeks
Sociodemographic information (height)
Height will be measured and recorded as centimeters (cm)
Measured: 6 weeks
Sociodemographic information (weight)
Weight will be measured and recorded as kilogram (kg)
Measured: 6 weeks
Trunk Muscle Endurance (McGill Endurance Test and Plank Test)
McGill Endurance Test:
- Lateral Bridge Test: used to evaluate trunk lateral muscle endurance. The time will be measured and recorded with a stopwatch in seconds. The test will be repeated once for the right and left sides.
- Biering-Sorenson Test: It will be used to evaluate the static endurance of the back extensors.
- Trunk flexor test: It will be used to evaluate the muscle endurance of the trunk flexors.
Plank Test: It will be used to evaluate whole body muscle endurance. It has a high reliability of 95 %.
For each test, the time until the body position is disrupted will be measured with a stopwatch and recorded in seconds.
Measured: 6 weeks
Chair Sit to stand test
It will be used to evaluate lower extremity proximal muscle strength and endurance. The individual will sit in the middle of the chair with his back upright, his feet on the floor, and his arms crossed in front of his chest. By starting the time with a stopwatch, the individual will be asked to perform the full standing and sitting movement as many times as possible in 30 seconds and the number of full stands will be recorded.
Measured: 6 weeks
6 minute walk test
It will be used to assess the functional capacity. At the end of the 6 minute, the distance walked will be recorded as meters (m).
Measured: 6 weeks
Fatigue Severity Scale
It will be used to evaluate the effect of fatigue on functionality. In this scale, which evaluates individuals' fatigue level in the last week, the scores from the questions (1: strongly disagree, 7: strongly agree) will be summed and divided by the number of questions to calculate the total score. Scores of 4 and above indicate serious fatigue.
Measured: 6 weeks
Pittsburgh Sleep Quality Index
Habitual sleep efficiency, sleep duration, use of sleeping pills, daytime dysfunction, sleep latency, sleep quality and sleep disturbance in the last month will be evaluated.
The total score obtained from the index, which is scored between 0-3, varies between 0-21. A total score between 0 and 4 points indicates good sleep quality, while a total score between 5 and 21 points indicates poor sleep quality.
Measured: 6 weeks
Revised Fibromyalgia Impact Questionnaire
Limitations and functional disability in individuals will be evaluated with this survey. The questionnaire consists of 21 questions and each question is evaluated on a numerical scale between 0-10. An increase in the score obtained from the survey indicates that the loss of function due to fibromyalgia (FM) increases.
Measured: 6 weeks
Fear-Avoidance Beliefs Questionnaire
It consists of 2 parts including questions about physical activities and work. In the questionnaire evaluated with a 7-point Likert-type scale, physical activities are scored between 0-24, while work-related questions are scored between 0-36. A high score indicates that the individual has high fear avoidance beliefs.
Measured: 6 weeks
Pain Self-Efficacy Questionnaire
It evaluates the degree of confidence in performing activities despite pain. It is a questionnaire that is practical due to its brevity (10 questions) and measures multiple domains of self-efficacy related to social and physical functions. It is a 7-point Likert-type scale. The total score ranges from 0 to 60, with higher scores indicating higher self-efficacy.
Measured: 6 weeks
Body Awareness Questionnaire
Body image will be assessed with this questionnaire. It consists of 4 subgroups (prediction of body reactions, sleep-wake cycle, prediction at the beginning of the disease, and attention to changes and reactions in body processes). Participants will be asked to give points between 1 and 7 for each of the 18 statements. A high score means high body awareness.
Measured: 6 weeks
Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ)
This questionnaire which consists of 30 items, will be used to evaluate the biopsychosocial status of individuals. Each item is scored on a 5-point Likert-type scale that can be scored between 0 (no/never) and 4 (yes/always). The higher the total score, the higher the individual's biopsychosocial situation is.
Measured: 6 weeks
Short form-36 (SF-36)
It will be used to assess the quality of life. It generally evaluates the perception of health, social and physical functions, vitality, mental health, role limitations due to physical and emotional distress, and body pain with a total of 36 items. Each title is calculated separately and scores are given between 0-100. A high score indicates good health and a low score indicates poor health.
Measured: 6 weeks
Treatment Satisfaction Evaluation
To determine the treatment satisfaction level, the individual will be asked to mark between 0 (very dissatisfied) and 10 (extremely satisfied) on a 10 centimeter (cm) horizontal line. The distance between the marked location and point 0 was recorded in centimeter (cm).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start10 Apr 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (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.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebru Kadıoğlu, PT, Principal investigator, Eastern Mediterranean UniversitySevim Oksuz, Asst.Prof.Dr, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277596
- Sponsor's protocol ID
- ETK00-2023-0101
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Apr 2024
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Progressive Clinical Pilates Exercises Applied as a Supervised and Home Program in Individuals With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06277596
- Acronym / sponsor ID
- ETK00-2023-0101
- Conditions
- Fibromyalgia
- Keywords
- Exercise, chronic pain, clinical pilates, Functional, Psychosocial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 26 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 aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50.
Detailed description
After the voluntary individuals with Fibromyalgia (FM) who meet the inclusion criteria are evaluated, they will be randomly divided into two groups: exercise group and home exercise group.
The same clinical Pilates program will be applied to both groups at the same dosage. Evaluations and treatment will be applied to both groups by the same physiotherapist. Individuals will perform the exercises 10 repetitions, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. For the home exercise group, all exercises will be shown and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervise clinical Pilates group | Experimental | Other: ExerciseClinical Pilates exercises will be performed 10 repetitions, 3 days a week, for 6 weeks, under the supervision of a physiotherapist. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. |
| Clinical Pilates as home exercise | Active comparator | Other: ExerciseThe same exercises will be shown to the home exercise group and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking. In the 3rd week, new exercises will be shown to individuals. It will be applied 10 times, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteer individuals between the ages of 20-50
- Diagnosed with fibromyalgia according to the American College of Rheumatology criteria
- Pain level 3 and above according to visual analogue scale.
- Individuals who are sedentary (who have not engaged in physical activity at least 3 days a week in the last 3 months) will be included in the study.
Key exclusion criteria (6 listed)
- Having additional rheumatic disease
- Using NSAIDs and antidepressant drugs
- Individuals with orthopedic, neurological and cardiopulmonary diseases that prevent them from exercising
- Pregnant women
- Malignancy
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 |
|---|---|---|
| ExerciseClinical Pilates exercises (basic and advanced stabilization exercises) | Other | Clinical Pilates as home exercise, Supervise clinical Pilates group |
Primary outcome
Visual Analog Scale ( VAS )
Time frame: 6 weeks
Pain during activities of daily living and at rest will be evaluated with the Visual Analogue Scale (VAS). The individual will be asked to mark the appropriate point on a 10-centimeter (cm) horizontal line between 0 (no pain) and 10 (unbearable pain) at both ends. The distance between the point marked by the individual and the start will be measured with a ruler in cm and recorded. A 2-point reduction in VAS is considered a clinically important improvement.
15 secondary outcomes
Sociodemographic information (age)
Time frame: 6 weeks
Sociodemographic information (height)
Time frame: 6 weeks
Sociodemographic information (weight)
Time frame: 6 weeks
Trunk Muscle Endurance (McGill Endurance Test and Plank Test)
Time frame: 6 weeks
Chair Sit to stand test
Time frame: 6 weeks
6 minute walk test
Time frame: 6 weeks
Fatigue Severity Scale
Time frame: 6 weeks
Pittsburgh Sleep Quality Index
Time frame: 6 weeks
Revised Fibromyalgia Impact Questionnaire
Time frame: 6 weeks
Fear-Avoidance Beliefs Questionnaire
Time frame: 6 weeks
Pain Self-Efficacy Questionnaire
Time frame: 6 weeks
Body Awareness Questionnaire
Time frame: 6 weeks
Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ)
Time frame: 6 weeks
Short form-36 (SF-36)
Time frame: 6 weeks
Treatment Satisfaction Evaluation
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
Ebru Kadıoğlu, PT principal investigator
Eastern Mediterranean University
Sevim Oksuz, Asst.Prof.Dr study director
Eastern Mediterranean 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 in people with Fibromyalgia, run by Eastern Mediterranean University at 1 site in Cyprus.
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 6 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 16 Apr 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 Cyprus. 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?
Contact Ebru Kadıoğlu, PT (5428734011 ext. +90, ebrukadioglu1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale ( VAS ) (time frame: 6 weeks). 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 Apr 2024.