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

NCT07148518 | Recruiting

• 1 other identifier: Gazi University 76
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

coronary artery disease; cardiopulmonary exercise testing; arterial stiffness; oxygen consumption

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

Secondary Outcomes (14)

• Peripheral Muscle Oxygenation

  Through study completion, an average of 1 year

• Energy Consumption

  Through study completion, an average of 1 year

• Peripheral Muscle Strength

  Through study completion, an average of 1 year

• Respiratory Muscle Strength

  Through study completion, an average of 1 year

• Respiratory Muscle Fatigue

  Through study completion, an average of 1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients diagnosed with coronary artery disease will be recruited.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 25530442 BACKGROUND

• 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.

  PMID: 17019302 BACKGROUND

• 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.

  PMID: 22083536 BACKGROUND

• 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.

  PMID: 2691824 BACKGROUND

• 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.

  PMID: 17449129 BACKGROUND

• 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.

  PMID: 36751297 BACKGROUND

• 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.

  PMID: 30318391 BACKGROUND

• 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.

  PMID: 29386200 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Naciye SEVİM, Pt.

  Gazi University

  STUDY CHAIR

• Özden SEÇKİN, Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Mehmet Rıdvan YALÇIN, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+90(312)2162647; meralbosnak@gazi.edu.tr

Naciye SEVİM, Pt.

CONTACT

+90(539)7713761; naciyesevim@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)