Resistance Training in Cardiovascular Disease Patients
- Conditions
- Coronary Artery DiseaseHeart Failure With Reduced Ejection Fraction
- Interventions
- Other: Aerobic interval training combined with high intensity resistance trainingOther: Aerobic interval training combined with low intensity resistance trainingOther: Aerobic interval training
- Registration Number
- NCT04638764
- Lead Sponsor
- General Hospital Murska Sobota
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- 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
- Unstable CHD
- Decompensated HF
- Uncontrolled arrhythmias
- Severe and symptomatic aortic stenosis
- Acute myocarditis, endocarditis, or pericarditis
- Aortic dissection
- Marfan syndrome
- Musculoskeletal limitations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic interval training with high loads resistance training Aerobic interval training combined with high intensity resistance training Patient to be randomised into "combined aerobic training with high loads resistance training group". Aerobic interval training with low loads resistance training Aerobic interval training combined with low intensity resistance training Patient to be randomised into "combined aerobic training with low loads resistance training group". Aerobic interval training Aerobic interval training Patient to be randomised into "aerobic training training group".
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 total energy expenditure Change in kcal after 12 weeks compared to baseline Measured as change in kcal 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 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 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 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 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 Respiratory Exchange Ratio (RER) Change in % after 12 weeks compared to baseline Measured as percent change of RER during cardiopulmonary exercise test
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 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 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 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 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 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 Human Growth hormone (hGH) level Change in hGH level after 12 weeks compared to baseline Measured as change in hGH level
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
Trial Locations
- Locations (1)
Division of Cardiology, General Hospital Murska Sobota
🇸🇮Murska Sobota, Slovenia