KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Enrollment efficiency and Retention
研究概览
简要总结
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.
The main questions it aims to answer are:
- Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?
- Do participants follow the exercise program and wear a physical activity tracker as asked?
- Is the program safe and well tolerated?
Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:
- Usual pre-transplant care with a physical activity tracker
- Usual pre-transplant care plus an online exercise program
Participants will:
- Wear a wrist activity tracker to measure daily physical activity
- Complete a one-week baseline period before being assigned to a study group
- Be randomly assigned (like flipping a coin) to one of two groups
- If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback
- Answer questionnaires about their health, activity, and experience in the study
This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
详细描述
Adults with advanced chronic kidney disease (CKD) awaiting kidney transplantation often experience low physical activity, reduced physical function, and frailty. Poor physical function before transplant is associated with longer hospital stays, higher complication rates, delayed recovery, and worse post-transplant outcomes. Despite these risks, there are few scalable, evidence-based prehabilitation programs designed specifically for kidney transplant candidates.
KINETIC (Kidney Transplant Improvement through New Exercise Training to Increase Capacity) is a randomized clinical trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of a home-based, technology-enabled exercise prehabilitation program for adults on the kidney transplant waiting list.
Study Objectives The primary objective of this study is to evaluate the feasibility of delivering a 12-week, remote exercise prehabilitation program to kidney transplant candidates using an online exercise platform and wearable activity tracker.
Secondary objectives include evaluating:
Participant adherence to the exercise intervention Safety and tolerability of light-to-moderate intensity exercise in this population Changes in physical activity and physical function Participant-reported usability, satisfaction, and implementation outcomes Exploratory clinical outcomes relevant to transplant readiness and health status
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be at least 60 years old
- •receive transplant care at Penn Medicine
- •be on the kidney transplant waiting list
- •speak and comprehend English
- •be able to walk
- •have at least one physical function limitation OR at least one frailty metric
- •have access to a device capable of connecting to the Internet and downloading an application
- •be able to provide written informed consent
- •be cleared for participant via the Physical Activity Readiness Questionnaire (PARQ) verified against medical record or via written medical clearance from a clinician
排除标准
- •Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment
- •Be unable to self-monitor with study devices (i.e., have a condition such as dementia)
- •Not cleared by PARQ or receive written medical clearance to exercise
- •Participate in another physical activity study
- •Have any other reason they do not expect to be able to complete the study
研究组 & 干预措施
Usual Care with Physical Activity Tracker
Participants in this arm will continue to receive their usual pre-transplant care provided by the transplant center. In addition, participants will receive a wrist-worn physical activity tracker to measure daily activity, including step counts. Participants will be asked to wear the activity tracker throughout the study period, but they will not receive structured exercise programming or exercise-related coaching as part of the study.
干预措施: Active control (Other)
Exercise Prehabilitation Program with Physical Activity Tracker
Participants in this arm will continue to receive their usual pre-transplant care and will also take part in a 12-week, home-based exercise prehabilitation program. Participants will receive a wrist-worn physical activity tracker and access to an online exercise platform designed for people with kidney disease. The program includes live and on-demand exercise classes that focus on light-to-moderate intensity aerobic and resistance exercises. Participants will be asked to complete at least two exercise classes per week. The intervention is delivered remotely, and participants will complete a brief virtual orientation before starting the program.
干预措施: Exercise Rehabilitation Program with Physical Activity Tracker (Behavioral)
结局指标
主要结局
Enrollment efficiency and Retention
时间窗: Enrollment efficiency time period is study duration (anticipate up to 20 moths) and retention is 12 weeks of intervention period
Feasibility will be assessed by enrollment efficiency and participant retention. Enrollment efficiency will be calculated as the percentage of participants successfully enrolled after invitation. Thresholds of success include, ≥70% of potentially eligible agree to screening and ≥40% of eligible consent and enroll Retention will be measured as the percentage of enrollment participants who complete the 12-week study period. The threshold of successful retention is ≥70%.
Acceptability of the Intervention
时间窗: 12-weeks after randomization
Acceptability will be measured using the System Usability Scale (SUS), a validated questionnaire assessing usability and satisfaction with the study system. SUS scores will be calculated using standard scoring methods. Scores of 68 or higher will be considered indicative of acceptable usability. Quantitative findings will be supplemented with qualitative feedback from participants, including themes related to acceptability identified through end-of-study exit interviews.
Adherence
时间窗: 12 weeks after randomization
Adherence will be assessed as the percentage of study days with valid step count data and, for participants in the intervention arm, the percentage of completed exercise sessions out of those recommended during the 12-week intervention period. Feasible adherence will be defined as ≥70% of study days with valid step count data and ≥70% of participants in the intervention arm completed ≥2 exercise classes per week.
Adverse Events Related to Intervention
时间窗: Up to 12 weeks after randomization
Safety will be evaluated by documenting the number and type of adverse events occurring during the study period.
次要结局
- Change in Short Physical Performance Battery (SPPB) Score(13 and 25 weeks relative to baseline)
- Change in Daily Physical Activity (Step Counts)(12 weeks of intervention period)
- Changes in Health Related Quality of Life(13 and 25 weeks relative to baseline)
- Change in Frailty Status(13 and 25 weeks relative to baseline)
- Change in Gait Speed(13 and 25 weeks relative to baseline)
- Change in Chair Stand Time(13 and 25 weeks relative to baseline)
- Change in Handgrip Strength(13 and 25 weeks relative to baseline)
- Change in Self-Reported Physical Function(13 and 25 weeks after baseline)
- Changes in Digital Health Literacy(13 and 25 weeks relative to baseline)
- Changes in Self-Efficacy(25 and 13 weeks relative to baseline)
- Changes in Motivation for Physical Activity(25 and 13 weeks relative to baseline)
- Changes in Social Support(25 and 13 weeks relative to baseline)
- Changes in Self-reported Physical Activity(25 and 13 weeks relative to baseline)