NCT06887725

Brief Summary

Rheumatoid arthritis (RA) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. In recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with RA. However, many patients do not achieve disease remission and experience progressive functional impairment. According to 2003 data from the National Health Interview Survey in the United States, by 2030, approximately 25% of adults aged 18 years and older are expected to have doctor-diagnosed arthritis, and 9.3% of adults are expected to have arthritis-related activity limitations. In order for patients with RA to perform activities of daily living, it is very important for them to maintain their balance, i.e., their sense of proprioception. It is known that knee proprioception is decreased in RA. In addition, the presence of pain, decreased muscle strength, and functionality in patients with RA lead many of them to adopt a sedentary lifestyle. The main aim of this study was to evaluate the effects of exercise training on knee joint proprioception in individuals with RA. In addition, it also aims to examine how exercise training improves pain, functionality, performance, fear of falling, biopsychosocial status, and quality of life. The importance of this research is that it provides more scientific data for improving knee joint proprioception in individuals with RA and guides clinical practice. It is also expected to contribute to the development of a comprehensive approach to improving the quality of life of patients by demonstrating not only the physical but also the psychological and functional effects of exercise training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

March 16, 2025

Last Update Submit

March 16, 2025

Conditions

Keywords

exerciseproprioceptionbiopsychosocial modelkneemuscle strength

Outcome Measures

Primary Outcomes (1)

  • Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

    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 mounths

Secondary Outcomes (10)

  • Proprioception of the knee joint

    3 mounths

  • Health Assessment Questionnaire (HAQ)

    3 mounths

  • Hospital Anxiety Depression Scale (HADS)

    3 mounths

  • WOMAC Osteoarthritis Index

    3 mounths

  • McGill pain scale short form (SF McGill)

    3 mounths

  • +5 more secondary outcomes

Study Arms (2)

Training Group

EXPERIMENTAL
Other: Exercise

Kontrol Group

NO INTERVENTION

Interventions

The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise approach developed based on the biopsychosocial model. The parameters that form the basis of BETY are function-oriented core stabilization exercises, information management in pain, information management in mood, and information management in sexuality. BETY was shaped by the feedback of individuals with rheumatism who participated in regular exercise sessions for years and was introduced to the literature as a treatment method aiming to create changes in the cognitive structures of patients through exercise.

Training Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with RA
  • Being able to walk
  • Being between the ages of 40-65.
  • Accepting to participate in the study and approving the informed consent form.
  • Being literate and able to use technological devices.

You may not qualify if:

  • Having acute inflammatory pathology in the knee joint.
  • Knee arthroplasty surgery.
  • Intra-articular or systemic corticosteroid use in the last 3 months.
  • Having participated in an FTR program in the last 3 months.
  • Advanced musculoskeletal, cardiac or peripheral vascular disease.
  • Significant system or organ failure.
  • Having a disease that will affect cognitive functions such as Alzheimer's disease or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Akgoz A, Yakut Y, Tufekci O, Aktas BE, Sari EO, Barlak A, Bayramlar K, Apras Bilgen S, Korkusuz F, Unal E. Biopsychosocial model-based exercise improves muscle strength, proprioception, pain, function, and quality of life in rheumatoid arthritis patients with knee involvement: a randomized controlled clinical tiral. Rheumatol Int. 2025 Sep 6;45(9):221. doi: 10.1007/s00296-025-05976-3. No abstract available.

MeSH Terms

Conditions

Rheumatic FeverMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 20, 2025

Study Start

January 2, 2022

Primary Completion

December 20, 2024

Study Completion

December 24, 2024

Last Updated

March 20, 2025

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations