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

NCT ID: NCT07148518

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-20

Brief 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, 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.

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).

Conditions

Coronary Artery Disease (CAD)

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Lower Extremity Group

The 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.

No interventions assigned to this group

Upper Extremity Group

In 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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naciye SEVİM, Pt.

Role: STUDY_CHAIR

Gazi University

Özden SEÇKİN, Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Mehmet Rıdvan YALÇIN, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: CONTACT

meralbosnak@gazi.edu.tr

+90(312)2162647

Naciye SEVİM, Pt.

Role: CONTACT

naciyesevim@gazi.edu.tr

+90(539)7713761

Facility Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: primary

meralbosnak@gazi.edu.tr

+903122162647

Naciye SEVİM, Pt.

Role: backup

naciyesevim@gazi.edu.tr

+90(539)7713761

References

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.

Reference Type: BACKGROUND

PMID: 25530442 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17019302 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22083536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2691824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17449129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36751297 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30318391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29386200 (View on PubMed)

Other Identifiers

Gazi University 76

Identifier Type: -

Identifier Source: org_study_id