Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
研究概览
简要总结
Little is known about how exercise can affect heart function in stroke survivors.
This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation.
This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk.
详细描述
Purpose
To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends.
Methods
A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):
- BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
- AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years old
- •Has experienced a stroke
- •At least 12 months post-stroke
- •Able to stand independently
- •Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)
排除标准
- •Stroke of non-cardiogenic origin (aneurysm, tumour)
- •Actively engaged in other stroke rehabilitation services
- •Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
- •Resting blood pressure > 160/100 mmHg
- •Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
- •Has a pacemaker
- •Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- •Behavioural issues that would limit participation in exercise
研究组 & 干预措施
Aerobic Program
The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format
干预措施: Aerobic Exercise Program (Behavioral)
Balance and Flexibility Program
The Balance and Flexibility Program will be a non-aerobic intervention that will act as an Active Comparator. Stretching, balance exercises, yoga- or Tai Chi-style classes will be conducted.
干预措施: Non-aerobic Exercise Program (Behavioral)
结局指标
主要结局
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
时间窗: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
次要结局
- Ambulatory capacity and health related quality of life(assessed at 0, 6 and 8 months)
- Echocardiography measures(assessed at 0 and 6 months)
- Arterial stiffness and inflammatory biomarkers(assessed at 0, 6 and 8 months)
研究者
Janice Eng
Principal Investigator
University of British Columbia