Resistance Training in Cardiovascular Disease Patients

NCT04638764 | Unknown

• 1 other identifier: GH-MS-CVD-RT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Maximal aerobic capacity

  Measured as change in VO2 max (ml/kg/min)

  Change in maximal aerobic capacity at 12 weeks compared to baseline

• Change in Maximal voluntary contraction of knee extensors

  Measured as change in maximal isometric torque of knee extensors

  Change in maximal isometric torque at 12 weeks compared to baseline

Secondary Outcomes (28)

• Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Change in HOMA-IR at 12 weeks compared to baseline

• Change in glucose levels

  Change in glucose levels at 12 weeks compared to baseline

• Change in insulin levels

  Change in insulin levels at 12 weeks compared to baseline

• Change in systolic blood pressure during high and low load resistance exercise

  Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention

• Change in diastolic blood pressure during high and low load resistance exercise

  Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention

Study Arms (3)

Aerobic interval training with high loads resistance training

ACTIVE COMPARATOR

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

Other: Aerobic interval training combined with high intensity resistance training

Aerobic interval training with low loads resistance training

ACTIVE COMPARATOR

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

Other: Aerobic interval training combined with low intensity resistance training

Aerobic interval training

ACTIVE COMPARATOR

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

Other: Aerobic interval training

Interventions

Aerobic interval training combined with high intensity resistance training 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)).

Also known as: Aerobic and high intensity strength training

Aerobic interval training with high loads resistance training

Aerobic interval training combined with low intensity resistance training 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).

Also known as: Aerobic and low intensity strength training

Aerobic interval training with low loads resistance training

Aerobic interval training 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).

Also known as: Aerobic training

Aerobic interval training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital Murska Sobota: lead
• University of Ljubljana: collaborator
• University of Primorska: collaborator

Study Sites (1)

Division of Cardiology, General Hospital Murska Sobota

Murska Sobota, 9000, Slovenia

RECRUITING

Related Publications (5)

• 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.

  PMID: 36918949 DERIVED

• 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.

  PMID: 36367488 DERIVED

• 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.

  PMID: 36093154 DERIVED

• 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.

  PMID: 34301669 DERIVED

• 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.

  PMID: 33917770 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mitja Lainščak, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Tim Kambič, MKin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitja Lainščak, MD, PhD

CONTACT

+386 (0)2 5123733; mitja.lainscak@guest.arnes.si

Tim Kambič, MKin

CONTACT

tim.kambic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomisation with three parallel intervention groups

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 20, 2020
• Study Start: November 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: November 26, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)