The Effectiveness Of BETY In Fibromyalgia

NCT07034417 | Not Yet Recruiting

• 1 other identifier: 03-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia Syndrome (FMS) is a nonarticular, chronic rheumatic disorder of unknown etiology characterized by widespread musculoskeletal pain, impaired sleep quality, fatigue and the presence of identified tender points. Pain, the main symptom of the disease, is described as chronic and widespread. It is reported that the pain usually starts in the neck and shoulders but becomes widespread by being felt in various parts of the body during the day. Although it is difficult to localize the pain, it is reported to be localized to the paracervical and trapezius muscle and paralumbar and gluteal body parts. Cognitive Exercise Therapy Approach is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. This method has a unique scale that offers biopsychosocial assessment. There is the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ). Validity, reliability and sensitivity studies of BETY-BQ have been conducted in individuals with fibromyalgia. This study aims to examine the effect of BETY, an exercise approach developed on the basis of the biopsychosocial model, on individuals with fibromyalgia.

Conditions

Fibromyalgia

Keywords

biopsychosocial model; pain; functional capacity; depression; anxiety; quality of life

Outcome Measures

Primary Outcomes (1)

• Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

  The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.

  3 mounths

Secondary Outcomes (12)

• Hospital Anxiety Depression Scale (HADS)

  3 mounths

• Health Asessement Questionnaire (HAQ)

  3 mounths

• Short Form - 36

  3 mounths

• Pain Catastrophizing Scale

  3 mounths

• Fatigue Severity Scale

  3 mounths

Study Arms (2)

BETY Group

EXPERIMENTAL

BETY exercise sessions

Other: Exercise

Control Group

OTHER

Home exercise program

Other: Home exercise

Interventions

Exercise OTHER

Cognitive Exercise Therapy Approach

BETY Group

Home exercise OTHER

Home exercise

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with fibromyalgia
• years of age or older
• Being literate
• Having read and signed the informed consent
• Not exercising regularly in the last 3 months

You may not qualify if:

• Having a malignant disease
• Pregnancy
• Having chronic infectious or other rheumatologic diseases
• Having undergone a surgical operation in the last 6 months
• Collagen tissue disease
• History of peripheral vascular disease or neuropathy
• Presence of diseases that cannot be controlled and prevent exercise

Sponsors & Collaborators

• Aysima Barlak: lead
• Alanya Alaaddin Keykubat University: collaborator
• Alanya Alaaddin Keykubat University Alanya Training and Research Hospital: collaborator

Study Sites (1)

Alanya Alaaddin Keykubat University

Antalya, Alanya, 07425, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain; Depression; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Kübra Sargın Baskın, PT, MSc

CONTACT

5335664516; kubrasbaskin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT

Model Details: Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY)

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: June 24, 2025
• Study Start: July 12, 2025
• Primary Completion: August 30, 2025
• Study Completion (Estimated): February 12, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)