The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebru Kadıoğlu, PT; Phone Number: +90 5428734011; Email: ebrukadioglu1@hotmail.com
• Study Contact Backup: Name: Sevim Oksüz, Asst.Prof.Dr; Phone Number: +90 5488351465; Email: sevim.oksuz@emu.edu.tr

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99628
    • Recruiting
    • Eastern Mediterranean University
    • Contact: Sevim Oksüz, Asst.Prof.Dr; Phone Number: +90 5488351465; Email: sevim.oksuz@emu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervise clinical Pilates group; 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.	Other: Exercise; Clinical Pilates exercises (basic and advanced stabilization exercises)
Active Comparator: Clinical Pilates as home exercise; 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.	Other: Exercise; Clinical Pilates exercises (basic and advanced stabilization exercises)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic information (age)	Age will be recorded as years	6 weeks
Sociodemographic information (height)	Height will be measured and recorded as centimeters (cm)	6 weeks
Sociodemographic information (weight)	Weight will be measured and recorded as kilogram (kg)	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.	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.	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.	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.	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.	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.	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.	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).	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).	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.	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Principal Investigator: Ebru Kadıoğlu, PT, Eastern Mediterranean University; Study Director: Sevim Oksuz, Asst.Prof.Dr, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; chronic pain; Functional; Psychosocial; clinical pilates
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: ETK00-2023-0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No