Coronary Artery Disease (CAD)NCT07163741
Validity and Reliability of the 6-Minute Pegboard and Ring Test in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease (CAD), run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 25 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 32 patients diagnosed with coronary artery disease will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490
Ankara
Meral Boşnak Güçlü, Prof.Dr., 03122162647, meralbosnak@gazi.edu.tr
Aslınur Çakır, MSc., +905442350236, aslinur.cakir@gazi.edu.tr
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- coronary artery disease, 6 minute pegboard and ring test, functional upper extremity exercise capacity
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Respiratory Muscle Strength Assessment
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
Measured: Through study completion, an average of 1 year
Respiratory Function Assessment
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.
Measured: Through study completion, an average of 1 year
Peripheral Muscle Strength Assessment
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.
Measured: Through study completion, an average of 1 year
Assessment of Shortness of Breath and Fatigue
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.
Measured: Through study completion, an average of 1 year
Assessment of Chronotropic Response
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.
Measured: Through study completion, an average of 1 year
Heart Quality of Life (HeartQoL) Scale
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."
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion6 Jun 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Aslınur ÇAKIR, MSc., Study chair, Gazi UniversityNaciye Sevim, Pt., Principal investigator, Gazi UniversityMeral Boşnak Güçlü, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163741
- Sponsor's protocol ID
- 2025-1418
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15994402Evans JA, Whitelaw WA. The assessment of maximal respiratory mouth pressures in adults. Respir Care. 2009 Oct;54(10):1348-59.
PubMed 19796415Nashef 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.
PubMed 22378855
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 6-Minute Pegboard and Ring Test in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07163741
- Acronym / sponsor ID
- 2025-1418
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- coronary artery disease, 6 minute pegboard and ring test, functional upper extremity exercise capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 32 patients diagnosed with coronary artery disease will be recruited.
Key inclusion criteria (4 listed)
- Individuals diagnosed with coronary artery disease by conventional angiography or computed tomography coronary angiography,
Key exclusion criteria (5 listed)
- Individuals diagnosed with heart failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper Limb Functional Exercise Capacity
Time frame: 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
Time frame: 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.
6 secondary outcomes
Respiratory Muscle Strength Assessment
Time frame: Through study completion, an average of 1 year
Respiratory Function Assessment
Time frame: Through study completion, an average of 1 year
Peripheral Muscle Strength Assessment
Time frame: Through study completion, an average of 1 year
Assessment of Shortness of Breath and Fatigue
Time frame: Through study completion, an average of 1 year
Assessment of Chronotropic Response
Time frame: Through study completion, an average of 1 year
Heart Quality of Life (HeartQoL) Scale
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 15994402Miller 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.
- Background: PubMed 19796415Evans JA, Whitelaw WA. The assessment of maximal respiratory mouth pressures in adults. Respir Care. 2009 Oct;54(10):1348-59.
- Background: PubMed 22378855Nashef 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aslınur ÇAKIR, MSc. study chair
Gazi University
Naciye Sevim, Pt. principal investigator
Gazi University
Meral Boşnak Güçlü, Prof. Dr. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meral Boşnak Güçlü, Prof. Dr. (+90(312)2162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Functional Exercise Capacity (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163741, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.