NCT06702839

Brief Summary

No study has been found in the literature investigating the effectiveness of an innovative exercise approach defined on a biopsychosocial basis and having its own original scale on individuals with rheumatism over the years. The aim of this retrospective study was to determine the effects of the Cognitive Exercise Therapy Approach on the biopsychosocial conditions related to chronic pain; functionality, mood and quality of life of individuals with rheumatism diagnosis and to examine the effectiveness of BETY as a routine exercise approach by presenting the results compared with the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

November 22, 2024

Last Update Submit

December 1, 2025

Conditions

Keywords

biopsychosocialholisticexercisefunctioningsleepchronic pain

Outcome Measures

Primary Outcomes (1)

  • BETY-Biopsychosocial Questionnaire (BETY-BQ):

    it is a 30-item Likert-type scale developed through repeated statistics of feedback from rheumatic individuals who have participated in exercise sessions for many years, expressing the healing characteristics. It evaluates the individual from a biopsychosocial perspective with the subheadings of pain, functionality-fatigue, mood, sociability, sexuality and sleep. It is scored between 0 and 120. BETY-BQ evaluates the individual from a holistic perspective with six subheadings: pain (5 items), functionality (9 items), mood (10 items), sociability (3 items), sexuality (2 items) and sleep (1 item). A high score indicates a low biopsychosocial status.

    3 months

Secondary Outcomes (3)

  • Health Assessment Questionnaire (HAQ)

    3 months

  • Hospital Anxiety Depression Scale (HADS)

    3 months

  • Short Form - 36 (SF-36)

    3 months

Study Arms (2)

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

EXPERIMENTAL

3 days a week for 3 months

Other: BETY (Cognitive Exercise Therapy Approach )

Home exercise program

ACTIVE COMPARATOR

For 3 months

Other: Home exercise program

Interventions

Individuals with rheumatism were included in BETY sessions after the first session, which included functional gain with function-focused trunk stabilization exercises for their complaints and chronic pain management training based on neuroscience. BETY sessions included function-focused trunk stabilization exercises, chronic pain management, mood information management (dance therapy - authentic movement) as innovative. Individuals were included in a separate session of sexual information management and sleep education. 3 days a week for 3 months

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

Exercises have been shown and a brochure has been given The individuals in this group were mostly individuals from out of town who were given home exercise recommendations directed by a rheumatologist.

Home exercise program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients who were diagnosed as Ankylosing spondylitis (1984 modified New York criteria, RA (2010 ACR/EULAR criteria), PsA (2006 CASPAR criteria), SLE (2012 Systemic Lupus International Collaborating Clinics criteria), SSc (2013 ACR/EULAR criteria), pSS (American-European Consensus Group criteria), OA (1986 ACR criteria) and FMS (2016 ACR criteria)

You may not qualify if:

  • Patients who had severe cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazar, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rheumatic DiseasesMotor ActivityChronic Pain

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aykut Ozçadırcı

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Nur Banu Karaca, MSc. PT.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Orkun Tüfekçi, MSc. PT.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Aysima Barlak

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Ali Akdoğan, Prof. Dr.

    Hacettepe University

    STUDY DIRECTOR
  • Sedat Kiraz, Prof. Dr.

    Hacettepe University

    STUDY DIRECTOR
  • Edibe Unal, Prof. Dr.

    Hacettepe University

    STUDY CHAIR
  • Sevim Oksüz, PhD. PT.

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Şule Apraş Bilgen, Prof. Dr.

    Hacettepe University

    STUDY DIRECTOR
  • Robert D. Gerwin, MD.

    Johns Hopkins University

    STUDY DIRECTOR
  • Rinnie Geenen, Prof. Dr.

    Utrecht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 25, 2024

Study Start

August 1, 2017

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 2, 2025

Record last verified: 2025-12

Locations