Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training
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.
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.
Interventions
OTHERAerobic 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)).
OTHERAerobic 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).
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).
Sponsors
University of Ljubljana
University of Primorska
General Hospital Murska Sobota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.
Intervention model description
Cluster randomisation with three parallel intervention groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal aerobic capacity | Change in maximal aerobic capacity at 12 weeks compared to baseline | Measured as change in VO2 max (ml/kg/min) |
| Change in Maximal voluntary contraction of knee extensors | Change in maximal isometric torque at 12 weeks compared to baseline | Measured as change in maximal isometric torque of knee extensors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Change in HOMA-IR at 12 weeks compared to baseline | Measured as change in HOMA IR (%) |
| Change in glucose levels | Change in glucose levels at 12 weeks compared to baseline | Measured as change in glucose levels (mmol/L) |
| Change in insulin levels | Change in insulin levels at 12 weeks compared to baseline | Measured as change in insulin levels |
| 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 | Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values |
| 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 | Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) |
| Change in heart rate during high and low load resistance exercise | Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention | Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise) |
| Change in rating of perceived exertion during high and low load resistance 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 | Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise) |
| Change in Short Physical Performance Battery (SPPB) total score | Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline | Measured as change in points of the SPPB after 12 weeks compared to baseline |
| Change in time of the Up and Go test | Change in seconds of the Up and Go test after 12 weeks compared to baseline | Measured as change of time (s) in Up and Go test |
| Change in Grip strength test (kg) | Change in kg of Grip strength test after 12 weeks compared to baseline | Measured as change of kg in Grip strength test |
| Change in Arm curl test (number of repetitions) | Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline | Measured as change of number of repetitions in Arm curl test |
| Change in time of the Sit to stand test | Change in seconds of the Sit to stand test after 12 weeks compared to baseline | Measured as change in time (s) of the Sit and stand test |
| Change in One Leg Heel Raise test (number of repetitions) | Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline | Measured as change of number of repetitions in One leg heel raise test |
| Change in Interleukin 6 (IL-6) level | Change in IL-6 level after 12 weeks compared to baseline | Measured as change in IL-6 level |
| Change in sedentary activity level | Change in minutes of sedentary activity after 12 weeks compared to baseline | Measured as change in minutes spent in sedentary activity level using accelerometry data |
| Change in moderate to vigorous physical activity level | Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline | Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data |
| Change in the Back Scratch test | Change in cm of the Back Scratch test after 12 weeks compared to baseline | Measured as change in cm of the Back Scratch test |
| Change in the Chair Sit and Reach test | Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline | Measured as change in cm of the Chair Sit and Reach test |
| Change in Stork balance test | Change in seconds of the Stork balance test after 12 weeks compared to baseline | Measured as change in seconds of the Stork balance test |
| Change in Short form Health related quality of life questionnaire (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 | Measured as change in score of the SF-12 |
| Change in Patients health questionnaire score (PHQ-9) | 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 | Measured as change in points of PHQ-9 questionnaire |
| Change in Respiratory Exchange Ratio (RER) | Change in % after 12 weeks compared to baseline | Measured as percent change of RER during cardiopulmonary exercise test |
| Change in Ve/VCO2 slope ratio | Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline | Measured as change in VE/VCO2 slope |
| Change in Tumor necrosis factor alpha (TNF-alpha) level | Change in TNF-alpha level after 12 weeks compared to baseline | Measured as change in TNF-alpha |
| Change in Insulin like Growth Factor 1 (IGF-1) | Change in IGF-1 level after 12 weeks compared to baseline | Measured as change in IGF-1 level |
| Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) | Change in NT-proBNP level after 12 weeks compared to baseline | Measured as change in NT-proBNP level |
| Change in total energy expenditure | Change in kcal after 12 weeks compared to baseline | Measured as change in kcal using accelerometry data |
| Change in Human Growth hormone (hGH) level | Change in hGH level after 12 weeks compared to baseline | Measured as change in hGH level |
Countries
Slovenia
Contacts
Primary ContactMitja Lainščak, MD, PhD
Backup ContactTim Kambič, MKin
Outcome results
None listed