Validity and Reliability of the 6-Minute Pegboard and Ring Test in Patients With Coronary Artery Disease

Not yet recruiting

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT07163741
• Lead Sponsor: Gazi University

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.

Detailed Description

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.

Within the scope of the study, at least 32 patients diagnosed with coronary artery disease (CAD) will undergo the "6-Minute Pegboard and Ring Test" (6-PBRT), which assesses upper extremity functional exercise capacity, and the upper extremity cardiopulmonary exercise test, which assesses maximal exercise capacity, on two separate days, 48 hours apart. The 6-Minute Pegboard and Ring Test will be repeated twice, 1 hour apart, by the same evaluator. Before and after the test, heart rate (HR), oxygen saturation, respiratory frequency, arm fatigue, general fatigue, and dyspnea parameters will be assessed. In the 6-PBRT, heart rate and oxygen saturation will be measured with a pulse oximeter (Soulfix Fingertip Oximeter Pulse Oxygen Meter, ABD); fatigue and dyspnea will be assessed with the Modified Borg Scale (MBS); and respiratory frequency will be assessed by counting the number of breaths taken per minute. Patients' respiratory muscle strength will be assessed using a portable oral pressure monitor (Micro Medical MicroRM, UK); respiratory function tests will be performed using a spirometer (Cosmed, Class II/Internally Powered Equipment, Italy); and peripheral muscle strength will be assessed using a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA). Patients' quality of life will be assessed using the "Heart Quality of Life Scale in Coronary Artery Disease Patients." All assessments and tests will be explained in detail to the patient beforehand.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-09-15
• Primary Completion: 2026-06-06
• Study Completion: 2026-09-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Upper Limb Functional Exercise Capacity	Through study completion, an average of 1 year	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.
Maximal Exercise Capacity	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Chronotropic Response	Through study completion, an average of 1 year	A chronotropic response is the increase in heart rate in response to physical activity or exercise. Conversely, the absence of an increase in heart rate due to exercise or an inadequate increase in heart rate is defined as chronotropic insufficiency \[14\]. Chronotropic insufficiency can be assessed using the chronotropic index, which uses the maximal heart rate achieved during exercise testing and the resting heart rate.
Heart Quality of Life (HeartQoL) Scale	Through study completion, an average of 1 year	The scale consists of 14 items and two subscales: physical (10 items) and emotional (4 items). Each item on the HeartQoL Scale is scored between 0 and 3, with 3 indicating "no discomfort" and 0 indicating "very much discomfort."
Respiratory Function Assessment	Through study completion, an average of 1 year	Dynamic lung volumes will be assessed using a spirometer (Cosmed, Class II/Internally Powered Equipment, Italy) in an upright sitting position with the nose closed, according to the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Pulmonary function testing will measure FVC, FEV1, FEV1/FVC, peak expiratory flow (PEF), and FEF 25-75% flow rate. The best of three technically acceptable maneuvers with 95% agreement will be selected for statistical analysis.
Respiratory Muscle Strength Assessment	Through study completion, an average of 1 year	To assess respiratory muscle strength, voluntary maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using an electronic, portable oral pressure measuring device (Micro Medical MicroRM, UK) according to ATS/ERS criteria. Participants will be seated upright in a chair and asked to inhale deeply to their total lung capacity, then exhale rapidly and forcefully to their residual lung volume. To measure MEP, patients will be asked to exhale to their residual lung capacity, then inhale rapidly and forcefully to their total lung capacity. During the measurement, participants will be given verbal prompts to support the measurement. Measurements will continue until the difference between each best measurement is less than 5% or 5% H₂O. The participant's best measurement will be recorded. As a result of the measurements, the equations prepared by Evans and his colleagues will be used to calculate the expected values appropriate to the age and gender of the
Peripheral Muscle Strength Assessment	Through study completion, an average of 1 year	Patients' peripheral muscle strength will be assessed using a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA) for the upper extremities (deltoid muscle strength) and quadriceps muscle strength for the lower extremities (quadriceps muscle strength). Patients will be seated unsupported, with the arm in 90-degree abduction and flexion, and quadriceps muscle strength will be assessed with the knee in 90-degree extension. These measurements will be repeated three times on the right and left sides, and the best measurements will be recorded in Newtons (N) and used in the analysis. The reference equations of Andrews et al. will be used to calculate expected values based on age, gender, and body weight.
Assessment of Shortness of Breath and Fatigue	Through study completion, an average of 1 year	Patients' perception of shortness of breath and fatigue at rest and during activities of daily living will be assessed using the modified Borg Scale. Additionally, shortness of breath and general body and arm fatigue during exercise testing will be assessed using the modified Borg Scale.

Trial Locations

Locations (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490; Ankara, Turkey (Türkiye)