COVID-19 之后的居家锻炼远程康复 (BOOST)
高风险退伍军人的居家锻炼远程康复：COVID-19 暴露和社会经济因素的影响
The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.
研究概览
详细说明
There is an urgent need to understand the lasting impact of COVID-19 on the cardiopulmonary system to improve physical function and prevent long-lasting disability. Pertinent knowledge gaps regarding the post-recovery physiology driving any impairments need to be addressed to improve the quality of life in Veterans with prior SARS-CoV-2 infection. Further, it is important to devise successful rehabilitation strategies that can be safely conducted in a Veteran's home. Hence, the investigators propose to utilize VA Video Connect to deliver a home based, supervised group exercise program to Veteran COVID-19 survivors. The objective of this exercise trial is to determine the influence of COVID-19 on cardiorespiratory fitness, pulmonary and physical function and to investigate the effect of a home-based exercise tele-rehabilitation on these outcomes. The study design includes rural and urban sites and investigators with a history of VA rehabilitation collaboration. Moreover, the investigators will explore healthcare disparities related to COVID-19 which are associated with functional decline and may affect sustainability of exercise rehabilitation strategies deployed, if necessary, under social distancing restrictions.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alice S Ryan, PhD
- 电话号码：(410) 605-7851
- 邮箱：Alice.Ryan@va.gov
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21201
- 招聘中
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
首席研究员：
- Alice S. Ryan, PhD
-
接触：
- Kristina Marcus, MS
- 电话号码：(410) 605-7000
- 邮箱：kristina.marcus@va.gov
-
-
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:
- Veteran
- documented COVID-19 > 90 days ago
- diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI > 30 kilograms per square meter (kg/m2)
Exclusion Criteria:
- myocardial infarction (within 3 months)
- exertional or unstable angina (chest pain that limits activity)
- severe congestive heart failure (EF < 20% in last year or NYHA Classification III or IV)
- uncontrolled hypertension (systolic blood pressure>180 &/or diastolic blood pressure> 110 millimeters of mercury at screening)
- screening electrocardiogram (EKG) with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
- poorly controlled diabetes mellitus (fasting blood sugar>200 milligrams per deciliter, random blood sugar > 299 milligrams per deciliter, or HbA1C > 10)
- treatment for cancer except skin cancer (within 3 months)
- peripheral vascular disease with claudication
- severe arthritis limiting ambulation
- neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy)
- end stage liver disease (decompensated liver disease)
- End stage renal failure (dialysis)
- severe pulmonary disease (home oxygen, admission for dyspnea or pneumonia within 1 month)
- high fall risk (history of falls, bone fracture)
- dementia (based on Evaluation to Consent)
- signs or symptoms of any medical comorbidity that would preclude exercise testing or training
- exercises on routine basis (structured aerobic exercise > 3 times per week)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tele-exercise
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. |
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. |
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 |
|---|---|---|
|
Change in volume of oxygen (VO2) peak
大体时间：Baseline and after 12 weeks tele-exercise
|
physical fitness, units are milliliters of oxygen per kilogram per minute (ml/kg/min) |
Baseline and after 12 weeks tele-exercise
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 2-minute step test
大体时间：Baseline and after 12 weeks tele-exercise
|
physical function, units are number of times |
Baseline and after 12 weeks tele-exercise
|
|
chair stands
大体时间：Baseline and after 12 weeks tele-exercise
|
muscular strength, units are number of times |
Baseline and after 12 weeks tele-exercise
|
合作者和调查者
调查人员
- 首席研究员：Alice S. Ryan, PhD、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.