NCT07354399

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Sep 2025Nov 2026

Study Start

First participant enrolled

September 26, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 8, 2025

Last Update Submit

January 14, 2026

Conditions

Keywords

Coronary Artery DiseaseResistance TrainingCardiac RehabilitationWomen

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 .

    From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (4)

  • Blood Biomarkers

    From enrollment to the end of treatment at 12 weeks.

  • Handgrip Strength

    From enrollment to the end of treatment at 12 weeks.

  • 30-Second Sit-to-Stand Test

    From enrollment to the end of treatment at 12 weeks.

  • Quality of Life Measure

    From enrollment to the end of treatment at 12 weeks.

Study Arms (3)

Aerobic Interval Training

ACTIVE COMPARATOR
Other: Aerobic Interval Training

Combined Training 1

EXPERIMENTAL
Other: Aerobic Interval TrainingOther: Traditional Resistance Training

Combined Training 2

EXPERIMENTAL
Other: Aerobic Interval TrainingOther: Prolonged Eccentric Phase Resistance Training

Interventions

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.

Aerobic Interval TrainingCombined Training 1Combined Training 2

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

Combined Training 1

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

Combined Training 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana (Department of Vascular Diseases, Division of Internal Medicine)

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (4)

  • 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: 31046441BACKGROUND
  • 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: 39214675BACKGROUND
  • 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: 35512240BACKGROUND
  • 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: 27647157BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease, Autosomal Dominant, 1Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Borut Jug, MD, Ph.D.

    University Medical Centre Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neža Nograšek, MKin

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 21, 2026

Study Start

September 26, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations