Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Ambulatory Blood Pressure
研究概览
简要总结
Two-center randomized, parallel, controlled trial which will compare a pragmatic combined training program with a health education program in 184 older adults with hypertension. This study will last 12 weeks with assessments conducted at baseline, previously to the group allocation, and after interventions. There is a set of secondary outcomes which show clinical importance to the elderly population and are possibly influenced by the tested intervention.
详细描述
The present protocol describes a randomized controlled trial that aims to evaluate blood pressure effects of a pragmatic combined training program, with low equipment needs, in comparison with a health education program. The sample is composed by 184 older adults, divided in two implementation centers. Randomization ratio will be 1:1 and interventions will last 12 weeks, with three weekly sessions for the exercise arm and one to the health education arm. In order to analyze the effects of interventions in a comprehensive way, a range of variables related to ambulatory blood pressure (primary outcome), physical fitness, vascular and autonomous function, together with emotional and cognitive aspects will be evaluated in a pre-post fashion. The study's hypothesis, as well as the sample size calculation and analysis plan, is based on a superiority expectation for the exercise program in comparison with the health education program, especially for the blood pressure control, functional capacity and quality of life. The present study was designed and will be conducted by a multidisciplinary staff and follows ethical and methodological recommendations for clinical trials. It is expected that this multicenter randomized trial will provide scientific evidences with a high applicability to the non-pharmacological management of hypertension in the elderly.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension diagnosis (through ambulatory blood pressure monitoring or medication use)
- •Verified ability to exercise
- •Unaltered pharmacological plan within previous 4 weeks
- •Willingness to participate in any of interventions
排除标准
- •Inability or refusal to give written consent
- •Myocardial infarction, revascularization proceedings, deep vein thrombosis
- •Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable defibrillator
- •Chronic pulmonary disease which requires the use of oxygen or steroidal therapy
- •Incidence of cardiovascular event, hospitalization or other severe health-related event during the experimental period
- •High alcohol consumption (over 14 doses per week)
- •Renal disease needing dialysis
- •Language, cognitive or hearing problems
- •Plans of moving to another city during the study
- •Living together with another person enrolled in the study
- •Osteoarticular or muscular injuries or another health conditions which generate inability to carry on the interventions
- •Progressive neurological disorders (Parkinson, multiple sclerosis, etc.)
- •Cancer treatment in the past 2 years
- •A medical report indicating exercise counterindication based cardiopulmonary exercise testing
结局指标
主要结局
Ambulatory Blood Pressure
时间窗: Change from baseline 24-hour systolic blood pressure at 12 weeks
24h ambulatory blood pressure measured through automatic oscillometric device
次要结局
- Geriatric Depression Symptoms(Change from baseline GDS-15 score at 12 weeks)
- Quality of life (QoL)(Change from baseline QoL score at 12 weeks)
- Autonomic function(Change from baseline beat-to-beat blood pressure variability at 12 weeks)
- Endothelial function, early adaptation(Change from baseline FMD at 6 weeks)
- Endothelial function(Change from baseline FMD at 12 weeks)
- Walking distance(Change from baseline walking distance at 12 weeks)
- Lower limbs functional capacity(Change from baseline SPPB score at 12 weeks)
- Cardiorespiratory fitness(Change from baseline VO2peak at 12 weeks)