NCT06753851

Brief Summary

The aim of the study was to evaluate the validity and reliability of 6-PBRT in patients with rheumatoid arthritis and to determine the applicability of the test for this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

December 23, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

exercise capacityrheumatoid arthritishand-grip

Outcome Measures

Primary Outcomes (1)

  • Six-minute pegboard and ring test

    The six minute pegboard and ring test (6-PBRT) will be used to assess upper extremity exercise capacity.

    First day and second day

Secondary Outcomes (3)

  • Maximal symptom-limited arm ergometer test

    First day

  • Hand-grip strength

    Second day.

  • Disabilities of the arm, shoulder and hand (DASH) questionnaire

    First day

Study Arms (1)

Rheumatoid arthritis group

All evaluations in the study will be completed on two separate days. First, demographic information, medical history and clinical findings of the patients will be recorded. On the first day, handgrip strength, DASH questionnaire and first 6-PBRT and arm ergometer test will be performed. The first 6-PBRT will be performed on the patients at least 30 minutes before the arm ergometer test and the patients will rest between the two tests. One week later, the same expert physiotherapist who performed the evaluations will perform the second 6-PBRT on the patients for reliability analysis.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid arthritis patients with disease remission between the ages of 18-75 and with a DAS-28 score below 2.6, who are followed up in the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kırşehir Ahi Evran University, will be included in the study.

You may qualify if:

  • Patients diagnosed with rheumatoid arthritis,
  • Ages of between 18-75 years,
  • Patients who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
  • Participated in a planned exercise program in the last three months,
  • Cognitive impairment that will cause difficulty in understanding and following exercise test instructions,
  • Contraindications to exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University, 63 / 5.000 Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Related Publications (3)

  • Bearne LM, Coomer AF, Hurley MV. Upper limb sensorimotor function and functional performance in patients with rheumatoid arthritis. Disabil Rehabil. 2007 Jul 15;29(13):1035-9. doi: 10.1080/09638280600929128.

  • Takeda K, Kawasaki Y, Yoshida K, Nishida Y, Harada T, Yamaguchi K, Ito S, Hashimoto K, Matsumoto S, Yamasaki A, Igishi T, Shimizu E. The 6-minute pegboard and ring test is correlated with upper extremity activity of daily living in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2013;8:347-51. doi: 10.2147/COPD.S45081. Epub 2013 Jul 23.

  • Lima VP, Almeida FD, Janaudis-Ferreira T, Carmona B, Ribeiro-Samora GA, Velloso M. Reference values for the six-minute pegboard and ring test in healthy adults in Brazil. J Bras Pneumol. 2018 May-Jun;44(3):190-194. doi: 10.1590/S1806-37562017000000388.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Başak KAVALCI KOL, PhD, PT

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR
  • Merve FIRAT, PhD, PT

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Figen TUNCAY, Prof. Dr., MD

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2024

First Posted

December 31, 2024

Study Start

January 26, 2025

Primary Completion

June 6, 2025

Study Completion

November 3, 2025

Last Updated

December 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

We will not share individual participant data as we store it securely in a locked cabinet and cloud database.

Locations