Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: A Randomized Controlled Trial of Efficacy With Economics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 2
- 主要终点
- 9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity
研究概览
简要总结
The purpose of this study is to develop a new intervention to improve the transition of patients from structured, supervised exercise to self-managed home- or approved community-based exercise programs in an effort to increase maintenance of exercise behaviour post cardiac rehabilitation (CR). The goal of the study is that those receiving the intervention will engage in at least 30 minutes of physical activity at a moderate or vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in the usual care group. The new intervention will be delivered by trained exercise facilitators (physiotherapists or exercise specialists) and will make use of: small group counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program demonstrations that would facilitate linkages between patients and approved community programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network (Peter Munk Cardiac Centre [PMCC] and Toronto Rehabilitation Institute [TRI]) sites. The study has a target enrollment of 604 participants.
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
- Single (Investigator)
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
- •Patient is currently participating in an on-site CR program of ≥ 8-week duration (to ensure that outcomes are not confounded by exposure to home-based or telephone-based case managed programs)
- •Patient has graduated from CR (to ensure that the study is evaluating an intervention to help sustain and improve maintenance of exercise behaviour
- •Patient has a documented diagnosis of CAD (to ensure homogeneity of the patient population)
- •Patient is 18 years of age or older
- •Patient is able and willing to provide informed consent
- •Able to walk unaided at 2 mph
排除标准
- •Patient has New York Heart Association class III or IV heart failure (because this might interfere with the ability to achieve recommended exercise levels and to ensure homogeneity of the patient population)
- •Patient is pregnant, lactating or planning to become pregnant during the study period (because this might interfere with the ability to achieve recommended exercise levels)
- •Patient is unable to read and understand English or French
- •Planning to leave the province or region in the next 12 months
- •Member of the participant's household is already participating in the study
- •The participant is unable, in the opinion of the qualified investigator, to participate in unsupervised exercise.
研究组 & 干预措施
Usual Care
Usual care for cardiac rehab graduates provided by the University of Ottawa Heart Institute Minto Prevention & Rehabilitation Centre and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network.
Exercise Facilitator Intervention
The intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.
干预措施: Exercise Facilitator Intervention (Behavioral)
结局指标
主要结局
9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity
时间窗: Baseline to 52 weeks
Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days. The results report the average minutes of exercise recorded across the full 9 days wearing the accelerometer.
9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity (>/= 10min Sessions)
时间窗: Baseline to 52 weeks
Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days. Outcome measure 2 reports the average number of minutes recorded over the full 9 days of wearing the accelerometer, but only when the exercise events last for at least 10 minutes. This differs from Primary Outcome 1 because Primary Outcome 1 is an average of all bouts of exercise regardless of sustained time.
次要结局
- Symptom Limited Graded Exercise Test With Electrocardiographic Monitoring Using a Ramp Protocol on a Treadmill(Baseline and 52 weeks)
- Quality of Life Measured by the the EuroQoL 5D Visual Analogue Scale(Baseline to 52 weeks)
- Cardiovascular Risk Factors Measured by Waist Circumference(52 weeks)
- Cardiovascular Risk Factors Measured by Systolic Blood Pressure.(52 weeks)
- Cardiovascular Risk Factors Measured by Body Mass Index(52 weeks)