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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Interval Training

    Other intervention

    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.

  • Traditional Resistance Training

    Other intervention

    Resistance training with traditional tempo (1-second ascent, 2-second descent) - squat exercise and horizontal pull.

  • Prolonged Eccentric Phase Resistance Training

    Other intervention

    Resistance training with prolonged eccentric phase tempo (1-second ascent, 5-second descent) - squat exercise and horizontal pull.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Aerobic Interval TrainingActive comparator 1 intervention
Group B: Combined Training 1Experimental treatment 2 interventions
Group C: Combined Training 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximal Aerobic Capacity

Maximal aerobic capacity (VO2peak) will be assessed using a modified Ramp protocol on the Schiller ERR 911 cycle ergometer in combination with the Cardiovit CS-200 Excellence ergo-spirometer (Schiller, Switzerland). Following baseline spirometry, participants will perform a warm-up phase of unloaded cycling for up to three minutes, after which the workload will increase incrementally by 10-25 W every minute until exhaustion or the appearance of clinical indications for test termination. Throughout the test, the supervisor will monitor for any signs or symptoms warranting termination, in accordance with the American Heart Association guidelines.

Time frame
From enrollment to the end of treatment at 12 week.
2

Lean Body Mass

Body composition, including lean body mass (also called fat-free mass; calculated by subtracting body fat weight from total body weight) and fat mass, will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) (Hologic, USA), which is considered the gold standard for evaluating body composition due to its high accuracy and reproducibility .

Time frame
From enrollment to the end of treatment at 12 weeks.

Secondary outcomes

1

Blood Biomarkers

As part of routine clinical blood draws, fasting blood samples will be obtained before the first and last training sessions. They will be analysed for standard clinical parameters (including blood lipids and others).

Time frame
From enrollment to the end of treatment at 12 weeks.
2

Handgrip Strength

Handgrip strength will be assessed using a hand dynamometer (Jamar). Participants will hold the dynamometer with the arm alongside the body and the elbow flexed at 90 degrees, and will be instructed to squeeze as hard as possible for 3-5 seconds. Three measurements will be performed for each hand, with 1 minute of rest between trials. The highest value obtained will be used for analysis.

Time frame
From enrollment to the end of treatment at 12 weeks.
3

30-Second Sit-to-Stand Test

Lower-limb functional strength will be assessed using the 30-second sit-to-stand test. Participants rise from and return to a seated position as many times as possible within 30 seconds, using a standard chair (43 cm) without armrests, with arms crossed over the chest and feet flat on the floor. The outcome is the number of fully completed stands in 30 seconds. If the participant is unable to stand without using the arms, the score is recorded as 0.

Time frame
From enrollment to the end of treatment at 12 weeks.
4

Quality of Life Measure

Health-related quality of life will be assessed using the Heart Quality of Life Questionnaire (HeartQoL). The questionnaire yields scores ranging from 0 to 3, with higher scores indicating better health-related quality of life. The overall HeartQoL score is calculated as the mean of all item responses and includes one global scale and two subscales (physical and emotional).

Time frame
From enrollment to the end of treatment at 12 weeks.

Other outcomes

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