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Coronary Artery Disease (CAD)NCT07148518

Comparison of Upper and Lower Limb Maximal Exercise Capacities and Arterial Stiffness in Patients With CAD

An observational study of Coronary Artery Disease (CAD), run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronary artery disease (CAD) significantly increases mortality rates in both developed and developing countries. In this condition, the impairment of arterial blood circulation leads to insufficient blood supply to the myocardium during both rest and exercise, resulting in symptoms such as angina pectoris, dyspnea… 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
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 1 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

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: 30 patients diagnosed with coronary artery disease will be recruited.

Who may be able to join

  • Adults aged 18-85 with coronary artery disease diagnosed by conventional or CT angiography
  • Clinically stable
  • Willing to participate

Who cannot join

  • Heart failure diagnosis
  • Moderate/severe valvular heart disease
  • Orthopedic, neurological, or pulmonary conditions limiting exercise testing/capacity
  • Contraindications per ACSM guidelines
  • Prior coronary artery bypass graft surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit, Ankara, Çankaya 06490

    Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Upper and Lower Limb Maximal Exercise Capacities, Arterial Stiffness, Muscle Oxygenation and Energy Consumption During Tests in Patients With Coronary Artery Disease

Coronary artery disease (CAD) significantly increases mortality rates in both developed and developing countries. In this condition, the impairment of arterial blood circulation leads to insufficient blood supply to the myocardium during both rest and exercise, resulting in symptoms such as angina pectoris, dyspnea, and fatigue. Patients, particularly due to their fear of experiencing angina pectoris, tend to adopt a sedentary lifestyle. This situation contributes to exercise intolerance and a reduction in exercise capacity among individuals with CAD. A review of the literature reveals a lack of studies investigating upper and lower extremity exercise capacity and the physiological responses during exercise testing in patients with CAD. Therefore, the aim of this study is to compare arterial stiffness, muscle oxygenation, respiratory muscle fatigue, energy expenditure, perceived dyspnea, and fatigue during upper and lower extremity exercise testing in patients with coronary artery disease.

Read the detailed description

As a consequence of atherosclerosis progresses with aging, the lumen of the arteries narrows and the arterial wall thickens. In patients with coronary artery disease, this process impairs arterial blood flow, resulting in insufficient blood supply to the myocardium. Consequently, due to the inability to meet the oxygen demands of the heart muscle both at rest and during exercise, patients experience symptoms such as angina pectoris, dyspnea, and fatigue. Particularly, fear of developing angina pectoris during physical activity leads patients to develop kinesiophobia and adopt a sedentary lifestyle. This condition further reduces their exercise capacity. In the literature, several studies have assessed the exercise capacity of these patients; however, these studies have predominantly utilized treadmill or cycle ergometers to evaluate lower extremity exercise capacity, and no study has been found that specifically investigates upper extremity exercise capacity. Considering that the upper extremities are used more frequently than the lower extremities during daily living activities, it is of particular importance to evaluate the upper extremity exercise capacity of patients. Moreover, upper extremity exercise testing provides an alternative means of assessment for patients with coronary artery disease who are unable to participate in lower extremity exercise tests due to neurological, vascular, or orthopedic problems. Compared to the lower extremities, the active muscle groups engaged during upper extremity exercise testing are smaller, which leads to lower metabolic demand and reduced peak oxygen consumption. This results in a lower cardiopulmonary workload during the exercise test. Therefore, it is necessary to investigate and compare upper and lower extremity exercise capacities, as well as the physiological responses elicited during exercise testing, in patients with coronary artery disease.

The primary aim of the study is to compare upper and lower extremity exercise capacities and arterial stiffness levels during exercise testing in patients with coronary artery disease.

The secondary aim of the study is to evaluate muscle oxygenation, energy expenditure, and the perception of dyspnea and fatigue during upper and lower extremity exercise testing in patients with coronary artery disease.

The primary outcomes are upper and lower maximal exercise capacities (Cardiopulmonary exercise tests) and arterial stiffness during cardiopulmonary exercise tests (Arteriograph) device).

Secondary outcomes are muscle oxygenation (Near-infrared spectroscopy) device, respiratory muscle fatigue (mouth pressure device), energy consumption (multi sensor activity device), the perception of dyspnea (Modified Borg Scale (MBS)) and fatigue (MBS).

Keywords
coronary artery disease, cardiopulmonary exercise testing, arterial stiffness, oxygen consumption
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 groups in NCT07148518
Study groupRoleWhat they receive
Lower Extremity GroupThe first test is the cardiopulmonary exercise test (CPET), which evaluates the maximal exercise capacity of the lower extremities and will be performed on a treadmill. During the test, the muscle oxygen of the individuals will be measured with a near-infrared spectrometer, and their energy consumption will be measured with a multisensory physical activity monitor. Additionally, both arterial stiffness, assessed with the arteriograph device, and respiratory muscle fatigue, evaluated using a mouth pressure measurement device, will be measured before and after the test.
Upper Extremity GroupIn the second test, the maximal exercise capacity for the upper limb will again be evaluated by CPET and performed on the arm ergometer. The second test will be conducted 48 hours after the lower extremity exercise test. During the test in the second group, as in the first test, muscle oxygen will be measured with a near-infrared spectrometer, and energy expenditure with a multisensory physical activity monitor. Furthermore, arterial stiffness, determined by the arteriograph device, and respiratory muscle fatigue, assessed through a mouth pressure measurement system, will both be evaluated pre- and post-test.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Arterial Stiffness [carotid-femoral pulse wave velocity (PWV)]

    Arterial stiffness will be non-invasively evaluated with using the SphygmoCor XCEL® device, which has established validity and reliability. The device will measure carotid-femoral pulse wave velocity (PWV) along with pulse values.

    Measured: Through study completion, an average of 1 year

  3. Arterial Stiffness [augmentation index (AIx)]

    Arterial stiffness will be non-invasively evaluated with using the SphygmoCor XCEL® device, which has established validity and reliability. The device will measure augmentation index (AIx) along with pulse values.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (14)
  1. Peripheral Muscle Oxygenation

    Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the upper, lower extremities and trunk for both tests. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.

    Measured: Through study completion, an average of 1 year

  2. Energy Consumption

    Energy consumption will be evaluated with the Multi sensor activity monitor. The patient wear the multi sensor physical activity monitor over the triceps muscle of the non-dominant arm during CPETs. Energy consumption (joule / day) will be measured with the multi-sensor physical activity monitor.

    Measured: Through study completion, an average of 1 year

  3. Peripheral Muscle Strength

    Isometric peripheral muscle strength will be measured with a portable hand dynamometer. Measurements will be repeated on the shoulder abductors and knee extensors three times on the right and left.

    Measured: Through study completion, an average of 1 year

  4. Respiratory Muscle Strength

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to ATS and ERS criteria.

    Measured: Through study completion, an average of 1 year

  5. Respiratory Muscle Fatigue

    Respiratory muscle fatigue in patients will be assessed both before and immediately after upper and lower extremity cardiopulmonary exercise testing by measuring maximal inspiratory pressure (MIP) using a mouth pressure measurement device in accordance with ATS/ERS criteria. Prior to the tests, measurements will be repeated at least five times until the difference between the two highest MIP values is less than 5% or 5 cmH₂O. Immediately after the tests, at least three measurements will be performed until the difference between the two best MIP values is less than 5% or 5 cmH₂O.

    Measured: Through study completion, an average of 1 year

  6. Pulmonary Function (Forced vital capacity (FVC))

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced vital capacity (FVC)was evaluated.

    Measured: Through study completion, an average of 1 year

  7. Pulmonary Function (Forced expiratory volume in first second (FEV1))

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced expiratory volume in first second (FEV1) was evaluated.

    Measured: Through study completion, an average of 1 year

  8. Pulmonary Function (FEV1/FVC)

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, FEV1/FVC was evaluated.

    Measured: Through study completion, an average of 1 year

  9. Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%))

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, Flow rate 25-75% of forced expiratory volume (FEF25-75%)was evaluated.

    Measured: Through study completion, an average of 1 year

  10. Pulmonary Function (Peak flow rate (PEF))

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, peak flow rate (PEF) was evaluated.

    Measured: Through study completion, an average of 1 year

  11. Physical Activity Level

    Physical activity will be evaluated with the Multi sensor activity monitor. The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity level will be measured with the multi-sensor physical activity monitor.

    Measured: Through study completion, an average of 1 year

  12. Chronotropic Response Assessment

    Chronotropic response assessment will be evaluated through exercise testing using the chronotropic index, which is calculated based on the maximal heart rate achieved during the exercise test and the resting heart rate.

    Measured: Through study completion, an average of 1 year

  13. Dyspnea Perception

    Dyspnea perception will be evaluated with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.

    Measured: Through study completion, an average of 1 year

  14. Fatigue Perception

    Fatigue perception will be evaluated with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means fatigue.

    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.

  1. First posted29 Aug 2025
  2. Study start1 Sep 2025
  3. Primary completion9 Jul 2026
  4. Study completion1 Aug 2026

Resources

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
Case crossover
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07148518
Sponsor's protocol ID
Gazi University 76
Status last verified
Aug 2026
First submitted
22 Aug 2025
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.

    PubMed 25530442
  • Secher NH, Volianitis S. Are the arms and legs in competition for cardiac output? Med Sci Sports Exerc. 2006 Oct;38(10):1797-803. doi: 10.1249/01.mss.0000230343.64000.ac.

    PubMed 17019302
  • Ranadive SM, Fahs CA, Yan H, Rossow LM, Agiovlasitis S, Fernhall B. Comparison of the acute impact of maximal arm and leg aerobic exercise on arterial stiffness. Eur J Appl Physiol. 2012 Jul;112(7):2631-5. doi: 10.1007/s00421-011-2238-z. Epub 2011 Nov 15.

    PubMed 22083536
  • Miles DS, Cox MH, Bomze JP. Cardiovascular responses to upper body exercise in normals and cardiac patients. Med Sci Sports Exerc. 1989 Oct;21(5 Suppl):S126-31.

    PubMed 2691824
  • Ghroubi S, Chaari M, Elleuch H, Massmoudi K, Abdenadher M, Trabelssi I, Akrout M, Feki H, Frikha I, Dammak J, Kammoun S, Zouari N, Elleuch MH. The isokinetic assessment of peripheral muscle function in patients with coronary artery disease: correlations with cardiorespiratory capacity. Ann Readapt Med Phys. 2007 Jun;50(5):295-301; 287-94. doi: 10.1016/j.annrmp.2007.03.012. Epub 2007 Mar 30. English, French.

    PubMed 17449129
  • Cakal B, Yildirim M, Emren SV. Kinesiophobia, physical performance, and health-related quality of life in patients with coronary artery disease. Postepy Kardiol Interwencyjnej. 2022 Sep;18(3):246-254. doi: 10.5114/aic.2022.122892. Epub 2022 Dec 17.

    PubMed 36751297
  • Alves AJ, Oliveira NL, Lopes S, Ruescas-Nicolau MA, Teixeira M, Oliveira J, Ribeiro F. Arterial Stiffness is Related to Impaired Exercise Capacity in Patients With Coronary Artery Disease and History of Myocardial Infarction. Heart Lung Circ. 2019 Nov;28(11):1614-1621. doi: 10.1016/j.hlc.2018.08.023. Epub 2018 Sep 19.

    PubMed 30318391
  • Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

    PubMed 29386200

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 3 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Exercise Capacity (time frame: Through study completion, an average of 1 year). The study lists 3 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 NCT07148518, which also lists 8 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 4 Aug 2026.

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