Resistance Training Added to Aerobic Interval Training to Improve Aerobic Capacity and Muscle Mass in Women With Coronary Artery Disease

Официальное название

Resistance Training Among Women With Coronary Artery Disease

Обзор

The goal of this clinical trial is to find out whether partly replacing aerobic interval training (AIT) with resistance training (RT) leads to greater improvements in physical fitness and muscle mass in women with coronary artery disease (CAD) during cardiac rehabilitation. The main questions this study aims to answer are: * Does combining RT (squats and pulling exercises with weights) with a reduced amount of AIT (cycling) improve aerobic fitness in the same way as AIT alone? * Does the combined training lead to greater improvements in muscle mass compared with AIT alone? * Does slow-speed RT (slower lowering phase) result in lower heart rate and blood pressure during exercise compared with normal-speed RT? Researchers will compare three exercise programs: * AIT only (control group), * AIT combined with normal-speed RT (1-second lifting, 2-second lowering), * AIT combined with slow-speed RT (1-second lifting, 5-second lowering). Participants will take part in a 12-week cardiac rehabilitation program and will train three times per week. At the start and end of the program, participants will complete a cycling fitness test, body composition assessment, blood sampling, two strength tests, and quality-of-life questionnaire.

Подробное описание

CAD remains one of the leading causes of death among women worldwide. Although cardiac rehabilitation programs with AIT are well established, the optimal way to include RT in this population remains unclear. Historically, RT was limited in patients with heart disease due to concerns about excessive blood pressure responses and cardiovascular risk. However, recent evidence shows that properly prescribed RT is safe and may significantly improves muscle strength, aerobic fiitness, and overall quality of life.

The study consists of two sequential phases. The first is a crossover feasibility phase designed to compare the acute hemodynamic responses (blood pressure, heart rate) and rate of perceived exertion between two RT protocols: (1) traditional high-load RT (1-second lift, 2-second descent) and (2) high-load RT with a prolonged eccentric phase (1-second lift, 5-second descent). The goal of this phase is to confirm the feasibility and short-term safety of both approaches before inclusion in the main trial.

The second phase is a three-arm, parallel-group randomized controlled trial. After baseline assessments, participants are randomized into one of three groups using block randomization with variable block sizes to ensure balanced allocation throughout recruitment.

The 12-week intervention includes three supervised sessions per week, totaling 36 visits. AIT follows a structured progression based on heart rate reserve, alternating between high- and low-intensity cycling intervals on a stationary ergometer. RT sessions consist of compound lower-body and upper-body movements (hex-bar squat and horizontal cable pull), performed at approximately 80% of one-repetition maximum. Training intensity, load progression, and repetition tempo are standardized across groups, ensuring equivalent time under tension per set.

To maintain participant safety, all exercise sessions are supervised by medical and rehabilitation staff, including a physiotherapist, nurse, and kinesiologist, with a cardiologist on call. Continuous heart rate monitoring and pre- and post-exercise blood pressure measurements are performed during each session. Any adverse events will be recorded and reviewed by the study physician.

Statistical analyses will follow the intention-to-treat principle.

Вмешательства

• Другое Aerobic Interval Training
  Interval cycling, performed at 70-80% of the heart rate reserve (HRR) as determined during the cardiopulmonary exercise test. The training is structured as alternating high- and low-intensity intervals.
• Другое Traditional Resistance Training
  Resistance training with traditional tempo (1-second ascent, 2-second descent) - squat exercise and horizontal pull.
• Другое Prolonged Eccentric Phase Resistance Training
  Resistance training with prolonged eccentric phase tempo (1-second ascent, 5-second descent) - squat exercise and horizontal pull.

Первичные конечные точки

• Maximal Aerobic Capacity [Срок оценки: From enrollment to the end of treatment at 12 week.]
• Lean Body Mass [Срок оценки: From enrollment to the end of treatment at 12 weeks.]

Вторичные конечные точки (4)

• Blood Biomarkers [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
• Handgrip Strength [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
• 30-Second Sit-to-Stand Test [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
• Quality of Life Measure [Срок оценки: From enrollment to the end of treatment at 12 weeks.]

Критерии участия

Критерии включения

• documented CAD,
• stable clinical status (at least 1 month since myocardial infarction and/or elective percutaneous coronary intervention, at least 3 months since cardiac surgery).

Критерии исключения

• based on the American Heart Association guidelines for resistance training in patients with CAD,
• pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• University Medical Centre Ljubljana (Department of Vascular Diseases, Division of Internal — Ljubljana

Публикации

• Hansen D, Abreu A, Doherty P, Voller H. Dynamic strength training intensity in cardiovascular rehabilitation: is it time to reconsider clinical practice? A systematic review. Eur J Prev Cardiol. 2019 Sep;26(14):1483-1492. doi: 10.1177/2047487319847003. Epub 2019 May 2. PMID 31046441
• Terada T, Pap R, Thomas A, Wei R, Noda T, Visintini S, Reed JL. Effects of muscle strength training combined with aerobic training versus aerobic training alone on cardiovascular disease risk indicators in patients with coronary artery disease: a systematic review and meta-analysis of randomised clinical trials. Br J Sports Med. 2024 Oct 22;58(20):1225-1234. doi: 10.1136/bjsports-2024-108530. PMID 39214675
• Kambic T, Sarabon N, Hadzic V, Lainscak M. Effects of high- and low-load resistance training in patients with coronary artery disease: a randomized controlled clinical trial. Eur J Prev Cardiol. 2022 Nov 8;29(15):e338-e342. doi: 10.1093/eurjpc/zwac063. No abstract available. PMID 35512240
• Douglas J, Pearson S, Ross A, McGuigan M. Chronic Adaptations to Eccentric Training: A Systematic Review. Sports Med. 2017 May;47(5):917-941. doi: 10.1007/s40279-016-0628-4. PMID 27647157

Идентификаторы

NCT: NCT07354399 · UKCLRehabVAKAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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