Resistance Training in Cardiovascular Disease Patients

Study Overview
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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.

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

Conditions
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Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Other: Aerobic interval training combined with high intensity resistance training
* Other: Aerobic interval training combined with low intensity resistance training
* Other: Aerobic interval training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomisation with three parallel intervention groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic interval training with high loads resistance training<br>Patient to be randomised into combined aerobic training with high loads resistance training group. | Other: Aerobic interval training combined with high intensity resistance training<br>* 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)).<br>* Other names: Aerobic and high intensity strength training;|
| Active Comparator: Aerobic interval training with low loads resistance training<br>Patient to be randomised into combined aerobic training with low loads resistance training group. | Other: Aerobic interval training combined with low intensity resistance training<br>* 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).<br>* Other names: Aerobic and low intensity strength training;|
| Active Comparator: Aerobic interval training<br>Patient to be randomised into aerobic training training group. | Other: Aerobic interval training<br>* 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).<br>* Other names: Aerobic training;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training