Coronary Artery Disease With Myocardial InfarctionVAKARNCT07354399
Resistance Training Added to Aerobic Interval Training to Improve Aerobic Capacity and Muscle Mass in Women With Coronary Artery Disease
A study testing Aerobic Interval Training, Traditional Resistance Training and Prolonged Eccentric Phase Resistance Training in people with Coronary Artery Disease With Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coronary Artery Disease With Myocardial Infarction
- What is being tested?
- Aerobic Interval Training, Traditional Resistance Training and Prolonged Eccentric Phase Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 26 Sep 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- based on the American Heart Association guidelines for resistance training in patients with CAD,
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana (Department of Vascular Diseases, Division of Internal Medicine)
Ljubljana, 1000
Neža Nograšek, MKin, +386 (0)40 283 959, neza.nograsek@gmail.com
Borut Jug, MD, Ph.D.
About this study
Official title: Resistance Training Among Women With Coronary Artery Disease
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Aerobic Interval Training, Traditional Resistance Training, Prolonged Eccentric Phase Resistance Training
- Keywords
- Coronary Artery Disease, Resistance Training, Cardiac Rehabilitation, Women
- Medical subject headings
- Coronary Artery Disease, Autosomal Dominant, 1, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Interval TrainingOther
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 TrainingOther
Resistance training with traditional tempo (1-second ascent, 2-second descent) - squat exercise and horizontal pull.
Prolonged Eccentric Phase Resistance TrainingOther
Resistance training with prolonged eccentric phase tempo (1-second ascent, 5-second descent) - squat exercise and horizontal pull.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Interval Training | Active comparator | Not described Receives: Other: Aerobic Interval Training |
| Combined Training 1 | Experimental | Not described Receives: Other: Aerobic Interval Training; Other: Traditional Resistance Training |
| Combined Training 2 | Experimental | Not described Receives: Other: Aerobic Interval Training; Other: Prolonged Eccentric Phase Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 week.
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 .
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (4)
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).
Measured: From enrollment to the end of treatment at 12 weeks.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
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).
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start26 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease With Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
- Investigators
- Borut Jug, MD, Ph.D., Principal investigator, University Medical Centre Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354399
- Sponsor's protocol ID
- UKCLRehabVAKAR
- Acronym
- VAKAR
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31046441Terada 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.
PubMed 39214675Kambic 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.
PubMed 35512240Douglas 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.
PubMed 27647157
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Among Women With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07354399
- Acronym / sponsor ID
- VAKAR / UKCLRehabVAKAR
- Keywords
- Coronary Artery Disease, Resistance Training, Cardiac Rehabilitation, Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Interval Training | Active comparator | Other: Aerobic Interval Training |
| Combined Training 1 | Experimental | Other: Aerobic Interval Training, Other: Traditional Resistance Training |
| Combined Training 2 | Experimental | Other: Aerobic Interval Training, Other: Prolonged Eccentric Phase Resistance Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- based on the American Heart Association guidelines for resistance training in patients with CAD,
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Interval TrainingInterval 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. | Other | Aerobic Interval Training, Combined Training 1, Combined Training 2 |
| Traditional Resistance TrainingResistance training with traditional tempo (1-second ascent, 2-second descent) - squat exercise and horizontal pull. | Other | Combined Training 1 |
| Prolonged Eccentric Phase Resistance TrainingResistance training with prolonged eccentric phase tempo (1-second ascent, 5-second descent) - squat exercise and horizontal pull. | Other | Combined Training 2 |
Primary outcome
Maximal Aerobic Capacity
Time frame: From enrollment to the end of treatment at 12 week.
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.
Lean Body Mass
Time frame: From enrollment to the end of treatment at 12 weeks.
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 .
4 secondary outcomes
Blood Biomarkers
Time frame: From enrollment to the end of treatment at 12 weeks.
Handgrip Strength
Time frame: From enrollment to the end of treatment at 12 weeks.
30-Second Sit-to-Stand Test
Time frame: From enrollment to the end of treatment at 12 weeks.
Quality of Life Measure
Time frame: From enrollment to the end of treatment at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 31046441Hansen 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.
- Background: PubMed 39214675Terada 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.
- Background: PubMed 35512240Kambic 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.
- Background: PubMed 27647157Douglas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Borut Jug, MD, Ph.D. principal investigator
University Medical Centre Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Interval Training, Traditional Resistance Training and Prolonged Eccentric Phase Resistance Training in people with Coronary Artery Disease With Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Jan 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neža Nograšek, MKin (+386 (0)40 283 959, neza.nograsek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Aerobic Capacity (time frame: From enrollment to the end of treatment at 12 week.). The study lists 2 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 NCT07354399, which also lists 4 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 21 Jan 2026.