Resistance Training in Cardiovascular Disease Patients (RT in CVD)

Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Aerobic interval training combined with high intensity resistance training; Other: Aerobic interval training combined with low intensity resistance training; Other: Aerobic interval training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitja Lainščak, MD, PhD; Phone Number: +386 (0)2 5123733; Email: mitja.lainscak@guest.arnes.si
• Study Contact Backup: Name: Tim Kambič, MKin; Email: tim.kambic@gmail.com

Study Locations

• Slovenia
  • Murska Sobota, Slovenia, 9000
    • Recruiting
    • Division of Cardiology, General Hospital Murska Sobota
    • Contact: Mitja Lainščak, MD, PhD; Email: mitja.lainscak@guest.arnes.si
    • Contact: Tim Kambič, MKin; Email: tim.kambic@gmail.com
    • Principal Investigator: Tim Kambič, MKin
    • Sub-Investigator: Vedran Hadžić, MD, PhD
    • Sub-Investigator: Jerneja Farkaš Lainščak, MD, PhD
    • Sub-Investigator: Nejc Šarabon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic interval training with high loads resistance training; Patient to be randomised into "combined aerobic training with high loads resistance training group".	Other: 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)).; Other Names: Aerobic and high intensity strength training
Active Comparator: Aerobic interval training with low loads resistance training; Patient to be randomised into "combined aerobic training with low loads resistance training group".	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).; Other Names: Aerobic and low intensity strength training
Active Comparator: Aerobic interval training; Patient to be randomised into "aerobic training training group".	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).; Other Names: Aerobic training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Measured as change in HOMA IR (%)	Change in HOMA-IR at 12 weeks compared to baseline
Change in glucose levels	Measured as change in glucose levels (mmol/L)	Change in glucose levels at 12 weeks compared to baseline
Change in insulin levels	Measured as 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	Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values	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	Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise)	Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in heart rate during high and low load resistance exercise	Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise)	Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in rating of perceived exertion during high and low load resistance exercise	Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise)	Change of rating of perceived exertion (score 0-10, 0-no exertion, 10-maximal exertion) during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in Short Physical Performance Battery (SPPB) total score	Measured as change in points of the SPPB after 12 weeks compared to baseline	Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
Change in time of the "Up and Go" test	Measured as change of time (s) in "Up and Go" test	Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
Change in Grip strength test (kg)	Measured as change of kg in Grip strength test	Change in kg of Grip strength test after 12 weeks compared to baseline
Change in Arm curl test (number of repetitions)	Measured as change of number of repetitions in Arm curl test	Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
Change in time of the Sit to stand test	Measured as change in time (s) of the Sit and stand test	Change in seconds of the Sit to stand test after 12 weeks compared to baseline
Change in One Leg Heel Raise test (number of repetitions)	Measured as change of number of repetitions in One leg heel raise test	Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
Change in total energy expenditure	Measured as change in kcal using accelerometry data	Change in kcal after 12 weeks compared to baseline
Change in sedentary activity level	Measured as change in minutes spent in sedentary activity level using accelerometry data	Change in minutes of sedentary activity after 12 weeks compared to baseline
Change in moderate to vigorous physical activity level	Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data	Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
Change in the Back Scratch test	Measured as change in cm of the Back Scratch test	Change in cm of the Back Scratch test after 12 weeks compared to baseline
Change in the Chair Sit and Reach test	Measured as change in cm of the Chair Sit and Reach test	Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
Change in Stork balance test	Measured as change in seconds of the Stork balance test	Change in seconds of the Stork balance test after 12 weeks compared to baseline
Change in Short form Health related quality of life questionnaire (SF-12)	Measured as change in score of the SF-12	Change in score of the Short form 12 items health related questionnaire (12 points -the lowest score, 47 points the highest score) after 12 weeks compared to baseline
Change in Patients health questionnaire score (PHQ-9)	Measured as change in points of PHQ-9 questionnaire	Change in score of the Patients health 9-item questionnaire (0 points-the best outcome, 27 points-the worse outcome) after 12 weeks compared to baseline
Change in Respiratory Exchange Ratio (RER)	Measured as percent change of RER during cardiopulmonary exercise test	Change in % after 12 weeks compared to baseline
Change in Ve/VCO2 slope ratio	Measured as change in VE/VCO2 slope	Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
Change in Tumor necrosis factor alpha (TNF-alpha) level	Measured as change in TNF-alpha	Change in TNF-alpha level after 12 weeks compared to baseline
Change in Interleukin 6 (IL-6) level	Measured as change in IL-6 level	Change in IL-6 level after 12 weeks compared to baseline
Change in Human Growth hormone (hGH) level	Measured as change in hGH level	Change in hGH level after 12 weeks compared to baseline
Change in Insulin like Growth Factor 1 (IGF-1)	Measured as change in IGF-1 level	Change in IGF-1 level after 12 weeks compared to baseline
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)	Measured as change in NT-proBNP level	Change in NT-proBNP level after 12 weeks compared to baseline

Collaborators and Investigators

• Sponsor: General Hospital Murska Sobota
• Collaborators: University of Primorska; University of Ljubljana
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 23, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): November 26, 2021

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery disease; heart failure; resistance training; aerobic training; cardiac rehabilitation; hemodynamic response
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GH-MS-CVD-RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No