Resistance Training in Cardiovascular Disease Patients

NCT ID: NCT04638764

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-11-26

Brief Summary

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In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training.

Detailed Description

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Exercise-based cardiac rehabilitation programmes have predominantly used aerobic-dynamic exercise modalities, whereas resistance training have been discouraged in patients with cardiovascular disease, due to safety concerns related to cardiovascular response (heart rate and blood pressure) during the exertion. Contrary to such concerns, recent hemodynamic studies have reported lower blood pressure and heart rate during higher intensity resistance training (\>70 % 1-RM) compared to lower intensity resistance training (\>40 % 1-RM). Furthermore, the latest meta analysis have demonstrated that combined resistance training with standard aerobic interval training has been superior than aerobic training alone in several aspects of health.

However, there is still huge heterogeneity in training intervention design, also there still lacks studies to further elucidate the effects of high intensity resistance training combined with aerobic training on physical performance (aerobic capacity, muscle strength, balance), body composition, quality of life, morbidity, mortality, etc. Therefore, the aim of this study was to examine the effects of high (70%-80 % 1-RM) versus low loads (30%- 40 % 1-RM) resistance training in combination with aerobic interval cycling (50 % -80% of baseline peak Power output) in coronary artery disease patients and patients with heart failure.

Conditions

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Coronary Artery Disease Heart Failure With Reduced Ejection Fraction

Keywords

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resistance training coronary artery disease heart failure hemodynamic response cardiac rehabilitation aerobic training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomisation with three parallel intervention groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.

Study Groups

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Aerobic interval training with high loads resistance training

Patient to be randomised into "combined aerobic training with high loads resistance training group".

Group Type ACTIVE_COMPARATOR

Aerobic interval training combined with high intensity resistance training

Intervention Type OTHER

Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)).

Aerobic interval training with low loads resistance training

Patient to be randomised into "combined aerobic training with low loads resistance training group".

Group Type ACTIVE_COMPARATOR

Aerobic interval training combined with low intensity resistance training

Intervention Type OTHER

Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM).

Aerobic interval training

Patient to be randomised into "aerobic training training group".

Group Type ACTIVE_COMPARATOR

Aerobic interval training

Intervention Type OTHER

Patients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing).

Interventions

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Aerobic interval training combined with high intensity resistance training

Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)).

Intervention Type OTHER

Aerobic interval training combined with low intensity resistance training

Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM).

Intervention Type OTHER

Aerobic interval training

Patients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing).

Intervention Type OTHER

Other Intervention Names

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Aerobic and high intensity strength training Aerobic and low intensity strength training Aerobic training

Eligibility Criteria

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Inclusion Criteria

* Stable patients with documented CAD with clinical event (\>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or
* Stable Heart Failure patients with documented reduced ejection fraction (\>40-45 %)
* age \>18 years
* NYHA class I-III
* Cardiopulmonary exercise test without ECG abnormalities

Exclusion Criteria

* Unstable CHD
* Decompensated HF
* Uncontrolled arrhythmias
* Severe and symptomatic aortic stenosis
* Acute myocarditis, endocarditis, or pericarditis
* Aortic dissection
* Marfan syndrome
* Musculoskeletal limitations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ljubljana

OTHER

Sponsor Role collaborator

University of Primorska

OTHER

Sponsor Role collaborator

General Hospital Murska Sobota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitja Lainščak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Murska Sobota; University of Ljubljana, Faculty of Medicine

Tim Kambič, MKin

Role: PRINCIPAL_INVESTIGATOR

General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport

Locations

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Division of Cardiology, General Hospital Murska Sobota

Murska Sobota, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Mitja Lainščak, MD, PhD

Role: CONTACT

Phone: +386 (0)2 5123733

Email: [email protected]

Tim Kambič, MKin

Role: CONTACT

Email: [email protected]

Facility Contacts

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Mitja Lainščak, MD, PhD

Role: primary

Tim Kambič, MKin

Role: backup

References

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Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Insulin resistance, lipids and body composition in patients with coronary artery disease after combined aerobic training and resistance training: a randomised, controlled trial. Diabetol Metab Syndr. 2023 Mar 15;15(1):47. doi: 10.1186/s13098-023-01017-w.

Reference Type DERIVED
PMID: 36918949 (View on PubMed)

Kambic T, Sarabon N, Hadzic V, Lainscak M. Physical activity and sedentary behaviour following combined aerobic and resistance training in coronary artery disease patients: A randomised controlled trial. Int J Cardiol. 2023 Jan 1;370:75-79. doi: 10.1016/j.ijcard.2022.10.157. Epub 2022 Oct 29.

Reference Type DERIVED
PMID: 36367488 (View on PubMed)

Kambic T, Sarabon N, Lainscak M, Hadzic V. Combined resistance training with aerobic training improves physical performance in patients with coronary artery disease: A secondary analysis of a randomized controlled clinical trial. Front Cardiovasc Med. 2022 Aug 24;9:909385. doi: 10.3389/fcvm.2022.909385. eCollection 2022.

Reference Type DERIVED
PMID: 36093154 (View on PubMed)

Kambic T, Sarabon N, Hadzic V, Lainscak M. Effects of high-load and low-load resistance training in patients with coronary artery disease: rationale and design of a randomised controlled clinical trial. BMJ Open. 2021 Jul 22;11(7):e051325. doi: 10.1136/bmjopen-2021-051325.

Reference Type DERIVED
PMID: 34301669 (View on PubMed)

Kambic T, Hadzic V, Lainscak M. Hemodynamic Response to High- and Low-Load Resistance Exercise in Patients with Coronary Artery Disease: A Randomized, Crossover Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3905. doi: 10.3390/ijerph18083905.

Reference Type DERIVED
PMID: 33917770 (View on PubMed)

Other Identifiers

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GH-MS-CVD-RT

Identifier Type: -

Identifier Source: org_study_id