NCT07163741

Brief Summary

Coronary artery disease, a cardiovascular disease, causes significant mortality and morbidity. Due to the impairment of arterial blood flow in coronary artery disease, the heart muscle cannot receive an adequate blood supply during exercise, resulting in symptoms such as chest pain, shortness of breath, and fatigue, which can lead to a decrease in exercise capacity. The 6-Minute Pegboard and Ring Test is a simple, rapid, and inexpensive assessment tool used to evaluate upper extremity exercise capacity. The purpose of this study was to assess the validity and reliability of the 6-Minute Pegboard and Ring Test in patients with coronary artery disease.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress67%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

September 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 2, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

coronary artery disease6 minute pegboard and ring testfunctional upper extremity exercise capacity

Outcome Measures

Primary Outcomes (2)

  • Upper Limb Functional Exercise Capacity

    The 6-minute pegboard ring test will be performed using two wooden blocks, each set at shoulder level and 20 cm above, for a total of 20 rings. Before the test, participants are instructed to simultaneously place wooden rings from the lower blocks onto the upper blocks using both hands and to continue the same process in reverse for 6 minutes. The goal of the test is to move as many rings as possible from bottom to top and top to bottom within six minutes. The total number of rings is recorded. Participants receive standard verbal encouragement each minute. Heart rate, blood pressure, shortness of breath, upper extremity fatigue, and overall fatigue are measured before and immediately after the test.

    Through study completion, an average of 1 year

  • Maximal Exercise Capacity

    Maximal Exercise capacity will be evaluated with Cardiopulmonary Exercise testing. The Cardiopulmonary Exercise Testing will be applied according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Respiratory Muscle Strength Assessment

    Through study completion, an average of 1 year

  • Respiratory Function Assessment

    Through study completion, an average of 1 year

  • Peripheral Muscle Strength Assessment

    Through study completion, an average of 1 year

  • Assessment of Shortness of Breath and Fatigue

    Through study completion, an average of 1 year

  • Assessment of Chronotropic Response

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

Patient with coronary artery disease group

The maximal exercise capacity for the upper limb will be evaluate by CPET and performed on the arm ergometer in addition to the upper limb functional exercise capacity will be evaluate by 6 minute pegboard and ring test.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

32 patients diagnosed with coronary artery disease will be recruited.

You may qualify if:

  • Individuals diagnosed with coronary artery disease by conventional angiography or computed tomography coronary angiography,
  • Clinically stable,
  • Ages between 18 and 85,
  • Volunteering to participate in the study will be included in the study.

You may not qualify if:

  • Individuals diagnosed with heart failure,
  • Those diagnosed with moderate-to-severe valvular disease,
  • Those with a history of orthopedic, neurological, or pulmonary disease that could affect exercise testing and exercise capacity,
  • Those with contraindications to exercise testing according to the American College of Sports Medicine (ACSM) criteria,
  • Those with a history of coronary artery bypass surgery will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.

    PMID: 15994402BACKGROUND
  • Evans JA, Whitelaw WA. The assessment of maximal respiratory mouth pressures in adults. Respir Care. 2009 Oct;54(10):1348-59.

    PMID: 19796415BACKGROUND
  • Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29.

    PMID: 22378855BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Aslınur ÇAKIR, MSc.

    Gazi University

    STUDY CHAIR
  • Naciye Sevim, Pt.

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Meral Boşnak Güçlü, Prof. Dr.

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Meral Boşnak Güçlü, Prof. Dr.

CONTACT

Aslınur Çakır, MSc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 9, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations