Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.
研究概览
简要总结
This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.
详细描述
This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney transplant candidates who meet criteria for the study will have wearable sensors placed for monitoring during the exercise session of their prehabilitation. The sensors will capture data during the single exercise session and transfer the data to a mobile health (mHealth) platform. The study aims to use the information from the sensors to develop future studies where the exercise is adjusted based on the sensor reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital
- •Male or Female, aged 55 or older
- •Provision of signed and dated informed consent by the participant
- •Willingness to comply with study procedures and the duration of the study
排除标准
- •Inability or contraindication to exercise
- •Refusal to participate
- •Inability to consent or effectively communicate
结局指标
主要结局
The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.
时间窗: Day 1
Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)
次要结局
- Muscle strength - Grip strength(Baseline)
- Muscle strength - Chair stand test(Baseline)
- Physical performance - Gait speed(Baseline)
- Physical performance - Timed up and go(Baseline)
- Physical performance - Walking test, 6-minute walk(Baseline)
- Physical performance - Walking test, 5-meter walk(Baseline)
- Respiratory capacity - Maximal inspiratory pressure(Baseline)
- Respiratory capacity - Adjust Inspiratory Muscle Trainer completion(Baseline)
- Physical therapy - Aerobic exercise(Day 1)
- Physical therapy - Resistance exercise(Day 1)
研究者
Atiya Dhala
Associate Professor of Clinical Medicine in Clinical Surgery
The Methodist Hospital Research Institute