The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease: Central And Peripheral Adaptations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of peak oxygen consumption during cardiopulmonary exercise testing
研究概览
简要总结
Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regimen for as long as six months after completion. Despite the benefits associated with regular exercise training (ET), adherence with supervised exercise-based CR remains low.
Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. The repetitive nature of this type of activity can become monotonous for the patient, affecting exercise adherence, compliance and training outcomes. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is still unclear.
In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization outcomes.
The purpose of this research project is twofold:
- To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in cardiovascular disease patients.
- to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in cardiovascular disease patients.
These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization. This experimental design will occur during 48 weeks 3 times per week with 4 assessment time points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET; M2) 6 months after starting the ET program and M3) 12 months at the end of the community-based ET program.
详细描述
Cardiac Rehabilitation (CR) of patients with Cardiovascular Disease (CVD) has been practiced in Europe to varying degrees since the early 1970s. CR is a comprehensive, long-term program involving medical evaluation, prescribed Exercise Training (ET), cardiac risk factor modification, education and counselling. These programs are designed to limit the physiologic and psychological effects of cardiac illness, reduce the risk for sudden death or re-infarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients. Furthermore, it is a safe, useful and an effective treatment for patients with coronary artery disease (CAD), particularly after myocardial infarction, but also for patients with cardiac interventions and chronic stable heart failure.
Exercise adherence after a hospital-based CR program is reported to be poor with only 30% to 60% of those who complete a phase II CR program are still exercising 6 months later and after 12 months, up to 50 to 80% of participants failing to adhere to exercise. Despite the benefits associated with regular ET, adherence with supervised exercise-based CR remains low.
A brief review of meta-analysis studies that assess the impact of different types of exercise in short term outcomes for participants of CR will now be presented. The findings of a meta-analysis in 2015 indicated that high intensity interval training (HIIT) is more effective than moderate continuous training (MCT) for the improvement of both VO2 peak and the anaerobic threshold in patients with stable CAD. The greater improvement in VO2 peak following HIIT compared to MCT (4.6 ± 3.1 versus 2.8 ± 2.4 ml/kg/min) is important in the context of a 10-25% survival advantage with every 3.5 ml/kg/min improvement in VO2 peak.
Another meta-analysis in 2016, compared HIIT and MCT in their ability to improve patients aerobic exercise capacity and various cardiovascular risk factors. Ten studies with 472 patients were included for analyses (218 HIIT, 254 MCT) and the main conclusions were that HIIT improves the mean VO2 peak in patients with CAD more than MCT, although MCT was associated with a more pronounced numerical decline in patients resting heart rate and body weight.
Current CR guidelines recommend the inclusion of a standardized resistance training (RT) program. A recent meta-analysis of ET programs in patients with CAD revealed that the addition of RT training to MCT led to superior improvements in body composition, muscle strength, peak work capacity, and a trend for greater increases in VO2 peak. Similar to HIIT, RT has not been shown to compromise patient safety or program adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •angiographically documented coronary artery disease in at least one major epicardial vessel
- •myocardial infarction,
- •coronary revascularization (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or coronary artery stent),
排除标准
- •heart failure
- •unstable angina pectoris
- •heart transplants with either cardiac resynchronization therapy or implantable defibrillators
- •inability to comply with guidelines for participation in exercise testing and training
- •significant limiting and/or unstable comorbidities that would prevent full participation
结局指标
主要结局
Change of peak oxygen consumption during cardiopulmonary exercise testing
时间窗: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET
A symptom-limited ramp incremental cardiopulmonary exercise test, will be performed on a cycle ergometer (Ergostik, Geratherm Respiratory GmbH, Germany) with breath-by-breath gas exchange measurements. Each patient will be encouraged to exercise to exhaustion (20 Watt+20 Watt/min or 15 Watt+15 Watt/min or 10 Watt+10 Watt/min), as defined by intolerance, leg fatigue or dyspnea unless clinical criteria for test termination occurred. Peak oxygen capacity will be considered the highest attained VO2 during the final 30s of exercise. All patients should achieve a respiratory exchange ratio of \>1.1, an indicator of maximal effort.
Change of oxygen kinetics during submaximal test
时间窗: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET
The test load is set at 80% of the value of the work rate corresponding to the Anaerobic Threshold detected in the maximum test, which was performed first, or 50% of VO2 peak, if the Anaerobic Threshold could not be adequately determined. Cardiopulmonary data will be recorded for 5 minutes at rest followed by 1 minute unloaded pedaling. After unloaded pedaling, patients will perform the constant load test for 6 min at the work rate described above, followed by unloaded pedaling for 5min. To improve the confidence of the kinetic parameter determination, this test will be performed three times and the averaged profile will be used for the kinetic analysis.
次要结局
- Change of Lean Soft-Tissue(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Anaerobic Threshold Watts during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Respiratory Compensation Point VO2 during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Respiratory Compensation Point Heart Rate during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Respiratory Compensation Point Watts during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Total Haemoglobin of the vastus lateralis muscle at the submaximal test(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Maximal Strength(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Quality of Life(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Oxyhaemoglobin of the vastus lateralis muscle at the submaximal test(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Fat Mass(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Deoxyhaemoglobin of the vastus lateralis muscle at the submaximal test(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Bone Mineral Content(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Anaerobic Threshold VO2 during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Anaerobic Threshold Heart Rate during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Peak Heart Rate reached during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
- Change of Maximal Watts reached during cardiopulmonary exercise testing(At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET)
研究者
Maria Helena Santa-Clara Pombo Rodrigues
Assistant Professor
University of Lisbon