Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Maximal aerobic capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Unstable CHD
- •Decompensated HF
- •Uncontrolled arrhythmias
- •Severe and symptomatic aortic stenosis
- •Acute myocarditis, endocarditis, or pericarditis
- •Aortic dissection
- •Marfan syndrome
- •Musculoskeletal limitations
结局指标
主要结局
Change in Maximal aerobic capacity
时间窗: 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
时间窗: Change in maximal isometric torque at 12 weeks compared to baseline
Measured as change in maximal isometric torque of knee extensors
次要结局
- 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 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)
- 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)
- 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)
- Change in time of the "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)(Change in kg of Grip strength test after 12 weeks compared to baseline)
- Change in the Back Scratch test(Change in cm of the Back Scratch test after 12 weeks compared to baseline)
- 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)
- Change in total energy expenditure(Change in kcal after 12 weeks compared to baseline)
- Change in Ve/VCO2 slope ratio(Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline)
- Change in Arm curl test (number of repetitions)(Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline)
- Change in sedentary activity level(Change in minutes of sedentary activity after 12 weeks compared to baseline)
- Change in moderate to vigorous physical activity level(Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline)
- Change in the Chair Sit and Reach test(Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline)
- Change in Respiratory Exchange Ratio (RER)(Change in % after 12 weeks compared to baseline)
- Change in Tumor necrosis factor alpha (TNF-alpha) level(Change in TNF-alpha level after 12 weeks compared to baseline)
- Change in time of the Sit to 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)(Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline)
- 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)
- Change in Stork balance test(Change in seconds of the Stork balance test after 12 weeks compared to baseline)
- 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)
- Change in Interleukin 6 (IL-6) level(Change in IL-6 level after 12 weeks compared to baseline)
- Change in Human Growth hormone (hGH) level(Change in hGH level after 12 weeks compared to baseline)
- Change in Insulin like Growth Factor 1 (IGF-1)(Change in IGF-1 level after 12 weeks compared to baseline)
- Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)(Change in NT-proBNP level after 12 weeks compared to baseline)