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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Sevim Öksüz, Asst.Prof.Dr contact

5488351465 ext. +90

sevim.oksuz@emu.edu.tr

Cyprus1 site, 1 recruiting
  • Eastern Mediterranean University

    Famagusta, 99628

    Sevim Oksüz, Asst.Prof.Dr, 5488351465 ext. +90, sevim.oksuz@emu.edu.tr

    Recruiting

Other trials in Cyprus

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 groups in NCT06277596
Study groupRoleWhat they receive
Supervise clinical Pilates groupExperimentalClinical 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 exerciseActive comparatorThe 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.

  1. 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)
  1. Sociodemographic information (age)

    Age will be recorded as years

    Measured: 6 weeks

  2. Sociodemographic information (height)

    Height will be measured and recorded as centimeters (cm)

    Measured: 6 weeks

  3. Sociodemographic information (weight)

    Weight will be measured and recorded as kilogram (kg)

    Measured: 6 weeks

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted26 Feb 2024
  2. Study start10 Apr 2024
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

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)
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

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.

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