Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Exercise Adherence
研究概览
简要总结
Older sepsis survivors have poor physical function and need post-sepsis physical rehabilitation. Often times, sepsis survivors live far from research facilities and do not have access to rehabilitation services. Remotely delivered exercise intervention could be the key to improve physical function in this population. Therefore, the study proposes to recruit older sepsis survivors at discharge from the hospital to home and assign them to either exercise training or standard care.
详细描述
The proposed research will use a multi-disciplinary expertise of the University of Florida Sepsis and Critical Illness Research Center (SCIRC). For this project, the investigators will take advantage of the SCIRC's ongoing recruitment and monitoring of sepsis patients into an observational 1-year follow-up study. For this pilot, the investigators will approach and screen older sepsis survivors who get discharged from hospital to home. Potential participants will be approached within 5 days before discharge. The study will enroll 40 low-functioning (SPPB <6) older sepsis patients (≥55 years old). The enrolled subjects will be randomized to either digitally delivered and home-based exercise training program or standard care control group. All participants will receive tablets with the Blue Marble Health Platform (BMHP) app. For the control group, the app will be enabled only for the physical function assessments and for the rest of the time, only a health diary for logging daily activities will be available. Both groups will receive weekly phone calls from our research staff member to ask about their health and remind them of weekly charging of their tablets. The intervention group will receive daily reminders by text to perform the exercises for 30 min daily 5 days/week. Participants will be given wrist fitness tracking watches with step-counting and heart rate to measure adherence to an exercise intervention. At baseline and 12-week follow-up visits physical function assessments will be app-guided using the BMHP-validated physical function test similar to SPPB, with a blinded coordinator present via a video call to assist a participant with answering questions about the tests. The interventionists who will be calling the participants will be trained to maintain the same level of rapport to not jeopardize the study conditions.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to perform lower and upper-body movements
- •Sepsis survivor
- •Age 55 years and older
- •Being discharged to home from the hospital after surviving sepsis
- •Willingness to be randomized to either treatment or control group
- •Willingness to participate in all study procedures
- •Willingness to use the devices and technology in the study
排除标准
- •Failure to provide informed consent
- •Discharge to a long-term facility
- •Involvement in a structured rehabilitation program
- •Inability to perform lower or upper-body exercises (e.g. being in wheelchair)
- •Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- •Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score < 24
- •Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis
- •Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
- •Simultaneous participation in another intervention trial
- •Poor or no cellular internet service at the primary place of living.
研究组 & 干预措施
Home-based, digitally delivered exercise training program
干预措施: App-based exercise program (Other)
Standard care control group
干预措施: Standard of Care (Other)
结局指标
主要结局
Exercise Adherence
时间窗: Baseline to 3 months
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
Safety (Number of Adverse Events)
时间窗: Baseline to 3 months
Recording a number of adverse events during the study period.
次要结局
- 30-second Sit-to-Stand Test(Change between Baseline and 3 months)
- 4-Stage Balance Test(Change between Baseline and 3 months)