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

NCT06277596 | Recruiting

• 1 other identifier: ETK00-2023-0101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 ages of 20-50.

Conditions

Fibromyalgia

Keywords

Exercise; chronic pain; clinical pilates; Functional; Psychosocial

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (15)

• Sociodemographic information (age)

  6 weeks

• Sociodemographic information (height)

  6 weeks

• Sociodemographic information (weight)

  6 weeks

• Trunk Muscle Endurance (McGill Endurance Test and Plank Test)

  6 weeks

• Chair Sit to stand test

  6 weeks

Study Arms (2)

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.

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.

Other: Exercise

Interventions

Exercise OTHER

Clinical Pilates exercises (basic and advanced stabilization exercises)

Clinical Pilates as home exercise; Supervise clinical Pilates group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ebru Kadıoğlu, PT

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Sevim Oksuz, Asst.Prof.Dr

  Eastern Mediterranean University

  STUDY DIRECTOR

Central Study Contacts

Ebru Kadıoğlu, PT

CONTACT

5428734011; ebrukadioglu1@hotmail.com

Sevim Öksüz, Asst.Prof.Dr

CONTACT

5488351465; sevim.oksuz@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 26, 2024
• Study Start: April 10, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CY (1)