A Mobile-Health (mHealth) Fall Risk Prevention Intervention in Cardiac Rehabilitation: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Change in self-reported physical function
研究概览
简要总结
The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life
详细描述
Traditional cardiac rehabilitation programs typically prioritize aerobic exercise (e.g., walking, cycling, etc.) with much less emphasis on improving physical function and strength, which is very important in, for example, decreasing the risk of falling. Through this research, researchers will implement a comprehensive fall risk screening and physical function assessment supported with individualized therapeutic exercise(s). Researchers hope that this will decrease fall risk, enhance rehabilitation experience, and improve ability to perform tasks of daily living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study.
- •All participants must have access to a smart mobile device.
排除标准
- •Advanced dementia.
- •Wheelchair bound.
- •Vision loss.
- •Patients that underwent sternotomy within 12-weeks will be excluded from the upper body muscular strength/power assessment and associated upper body training. At the time of enrollment into CR, balance, upper body muscular fitness, and lower body muscular fitness will be assessed in each subject before they are randomized at a 1:1 allocation ratio into one of two parallel groups:
- •Standard early outpatient center-based supervised CR only (control; CR); or
- •Early outpatient center-based supervised CR plus individualized, home-based, m-Health delivered physical function training (experimental group; CR+PFt). Balance, upper body muscular fitness, and lower body muscular fitness and gait will be reassessed in each participant after 5-to-6 weeks of CR and again upon completion of the CR program. Patient reported measures of fall risk will be measured at baseline with the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit. Balance confidence, health-related quality of life, physical activity level, and functional capacity will be evaluated before and after CR and CR+PFt using the Activities-Specific Balance Confidence (ABC) Scale, the Dartmouth Primary Care Cooperative Information Project (COOP) charts, and the Duke Activity Status Index (DASI).
结局指标
主要结局
Change in self-reported physical function
时间窗: Baseline, approximately 7 to 14 weeks
Measured using the Duke Activity Status Index (DASI) a self-reported questionnaire to subjectively measure physical activity level and functional capacity. The questionnaire includes twelve questions with each question weighted differently to assign a total score. Functional capacity is graded based on the total score (i.e., Good = DASI \>31.95 or Poor = DASI \<31.95).
Change in fall risk
时间窗: Baseline, approximately 7 to 14 weeks
Measured using the Stop Elderly Accidents, Deaths, and Injuries (STEADI) assessment component which consists of 12 closed-ended questions. A score \>4 is considered at risk for falling.
Change in self-reported balance confidence
时间窗: Baseline, approximately 7 to 14 weeks
Measured using the Activities-Specific Balance Confidence Scale, a 16-item questionnaire that is scored with a Likert scale (0-100%). The subject is graded on level of confidence associated with fall risk while performing a range of daily activities with varying levels of difficulty. Higher scores greater confidence.
Change in health-related quality of life
时间窗: Baseline, approximately 7 to 14 weeks
Measured using the Dartmouth Primary Care Cooperative Information Project (COOP), a nine-question quality of life survey. There are nine categories including: physical condition, emotional condition, daily work, social activities, change in condition, overall condition, social support, quality of life and pain. Subjects will be graded with a total and sub-category score. Total scores range from 9-45 and a lower total score indicates a higher quality of life.
次要结局
未报告次要终点
研究者
Robert Scales
Principal Investigator
Mayo Clinic