The PREPARE for COVID Trial
PRomoting Exercise During the Pandemic to Increase Activity and Reduce Effects of Social Isolation for COVID: The PREPARE for COVID Trial
研究概览
详细说明
Background:More than 6.5 million Canadians are > 65 years of age. Over half of older Canadians live with multiple comorbidities, leaving them at high risk of adverse outcomes of COVID-19. Social isolation and physical distancing orders are especially important to protect the health of this high-risk population. Vulnerable older Canadians are also at high risk of physical and mental health deterioration caused by the physical distancing meant to protect them from COVID-19. Effective management of the COVID-19 pandemic and its consequences will require evidence-based strategies to support isolated vulnerable older Canadians. Exercise interventions can reduce the adverse health effects of social isolation and demonstrate larger effect sizes in older people with comorbidities. However, no exercise interventions have been tested in an acute isolation scenario such as the COVID-19 pandemic, which also requires that exercise interventions be home-based and remotely supported, presenting unique challenges to participation and adherence.
Our team is uniquely positioned re-orient proven and robust programming, supported by a national network of investigators and existing infrastructure. We can immediately launch a large-scale trial to test the effectiveness of a remotely supported home exercise program (designed in partnership with vulnerable older Canadians) to mitigate the negative consequences of physical distancing to keep older Canadians healthy and safe from COVID-19. We hypothesize that participation in the PREPARE program will decrease the individual, health system and population health impacts of COVID19 induced physical distancing and social isolation.
Research aims:Estimate the effectiveness of a remotely supported, home-based multimodal exercise program for older people with multiple comorbidities to improve our primary outcome: patient-reported disability 90-days after enrollment; secondary outcomes: patient-centered (depression, anxiety, quality of life, frailty, survival, 1-year disability scores, COVID19 severity) and system-relevant (admissions, emergency visits, institutionalization, costs, cost-effectiveness).
Methods: Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 3 Canadian hospitals. People >65 years old recently discharged home with >2 comorbidities will be included. Intervention: Three month supported home-based exercise program with demonstrated efficacy, feasibility and acceptability for vulnerable older people.
Outcomes and sample size: We will have 90% power to detect a clinically important difference of in our primary outcome (validated WHODAS tool, 90-days post-enrollment) with 372 participants (186/arm)
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 65 years of age or older
- 2 or more co-morbidities
- recent discharge from hospital
Exclusion Criteria:
- Inability to communicate in English or in French
- Unreachable by telephone
- Unstable cardiovascular or valvular disease
- Discharged to Long-Term Care
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Exercise Group
The home-based exercise program called the PREPARE program. Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility. |
A home-based exercise program guided by paper materials, weekly phone calls, and a DVD. Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility. |
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无干预：控制组
对照组将收到世界卫生组织关于65岁以上人群身体活动建议的小册子，以及老年人健康饮食指南。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-reported disability 90 days after enrollment
大体时间：Assessing change in score from baseline data collection to 90 days from enrollment
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The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used .
It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society.
Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.
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Assessing change in score from baseline data collection to 90 days from enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mental Health
大体时间：Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
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The Patient Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) are validated tools for diagnosing anxiety and depression.
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Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
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Function
大体时间：Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
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Step count using pedometer
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Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
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Health-related quality of life
大体时间：Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
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The EQ-5D-5L is a validated instrument with Canadian valuation statistics and national use, which informs incremental cost per quality-adjusted life year gained.
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Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
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Frailty
大体时间：Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
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The Clinical Frailty Scale (CFS) provides a global assessment of frailty.
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Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
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All-cause mortality.
大体时间：From enrollment to 12 months after enrollment.
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All deaths and death dates will be identified via chart review or telephone call.
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From enrollment to 12 months after enrollment.
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Health System - Emergency Department Visits
大体时间：Monthly for 12 months following enrollment.
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Monthly for 12 months following enrollment.
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Health System - Re-admission
大体时间：Monthly for 12 months following enrollment.
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Monthly for 12 months following enrollment.
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Health System - Transfer to Long-Term Care
大体时间：Monthly for 12 months following enrollment.
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Monthly for 12 months following enrollment.
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COVID-19 test results
大体时间：Monthly for 12 months following enrollment.
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Monthly for 12 months following enrollment.
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Safety [Adverse Events]
大体时间：Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
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Falls, cardiac or respiratory complications and unplanned healthcare encounters will be collected during the exercise treatment period for the exercise group.
For the control group, participants will be asked if they experienced any falls since the time of enrollment up until the day before surgery.
Unplanned healthcare encounters will also be collected during the time of enrollment to the final day of the exercise intervention for the intervention group through chart review.
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Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
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合作者和调查者
调查人员
- 首席研究员：Daniel I McIsaac, MD、The Ottawa Hospital Research Institute
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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