The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to first ambulation following kidney transplantation.
研究概览
简要总结
Pre-operative physical functioning has been acknowledged as a factor influencing post-operative complication risk, recovery progression and mortality risk. Current guidelines have yet to focus on the pre-operative period as a potential target to improve levels of physical functioning before renal transplantation. This project proposes the introduction of an exercise intervention pre-operatively to mitigate functional decline pre-operatively and improve post-operative outcomes following renal transplantation.
We hypothesize that a home-based exercise prehabilitation program prior to kidney transplantation will result in improved functional outcomes including the 6-minute walk test, 60-second timed sit to stand, Fried Frailty Score, quality of life and fatigue. Further we hypothesize that prehabilitation will result in improved outcomes regarding post-operative recovery, complication rate, length of stay and mortality.
Objectives
A) Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue
B) To determine whether a tailored home-based exercise program prior to kidney transplantation is feasible with regards to adherence in patients with Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD).
C) To determine if a prehabilitation program results in improved clinical outcomes within one week following Kidney Transplantation (KT) as well as at 30 and 90 days including but not limited to time to first ambulation, time to first bowel movement, postoperative complications (Clavien-Dindo classification), mortality and length of stay.
D) Quantify the differences described above, if any exist.
详细描述
This is a pilot study involving kidney transplant recipients who will be receiving a kidney from a live donor and receiving care at Vancouver General Hospital or St. Paul's Hospital.
Upon enrollment baseline demographics, including age, sex, BMI, ethnicity will be recorded. Baseline physical measures will include resting HR and BP, 6-minute walk test (6-MWT) (measuring HR and RPE every minute throughout), 30-second timed sit to stand (HR and RPE at the end), Fried Frailty score (Subjective: weight loss, energy level, physical activity levels - Objective: weakness, slowed walking speed), and a quality of life (QOL) and fatigue survey. These baseline measures will be recorded at onset of enrollment, every 3 months, again 1 week prior to KT, 4 weeks post operatively, and each month after for 5 months. This will add up to 6 months of follow up. The patient reported outcomes - post-op recovery survey and fatigue survey will also be completed on day 2 and day 5 post-operatively as well as 1, 2 and 4-weeks post-operatively.
Questionnaire Administration:
All questionnaires will be available electronically using Qualtrics as well via a paper copy. These will be administered based on patient preference; they will both be administered either electronically using Qualtrics or via a paper copy.
Participant Expectations: Assessment and Follow-up
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to physically participate in a home-based prehabilitation program and all functional outcome measures
- •Ability to read and write in English to respond to study questionnaires
- •Age = to or > 19 and any gender
- •Receiving care at Vancouver General Hospital or St. Paul's Hospital
- •Has been fully worked up for suitability for renal transplantation
- •Received physician clearance to participate
排除标准
- •Unstable pulmonary or symptomatic cardiac disease
- •Recent fracture or acute musculoskeletal injury that precludes the ability to exercise
- •4. Is unable to understand the purpose of the study, or cannot give written consent
研究组 & 干预措施
Exercise Group
All participants who are allocated to the exercise group will be asked to complete 4-5 days per week of mixed modality exercise incorporating aerobic, resistance, and flexibility training. The exercise intervention is prescribed based on the FITT principle: frequency, intensity, time and type. The 10-point Rating of Perceived Exertion (RPE) scale, which has been well correlated to target HR levels, will be used to monitor exercise intensity levels throughout the intervention, with participants instructed to maintain their intensity level at 3-5 during exercise sessions. Participant progression will be individualized and based on their subjective perceived intensity level using the RPE scale. In person instruction, from a member of the research team with standard first aid and CPR-C training, and an instructional handout and exercise log will be provided, as well as exercise resistance bands to perform resistance exercises.
干预措施: Exercise and Prehabilitation (Behavioral)
Control Group
This will consist of regular care, which is standard procedure.
结局指标
主要结局
Time to first ambulation following kidney transplantation.
时间窗: One week following kidney transplant.
Assessed in days.
Time to first bowel movement following kidney transplantation.
时间窗: One week following kidney transplant.
Assessed in days.
Change in 30-second timed sit to stand.
时间窗: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Change from baseline in number of repetitions completed in 30 seconds.
Change in number of participants with post operative complications.
时间窗: Change from 1 week following kidney transplant to 30 and 90 days post operatively.
Number of participants with post operative complications as assessed by Clavien-Dindo classification.
Length of hospital stay following kidney transplantation.
时间窗: One week following kidney transplant.
Assessed in days.
Change in Fried Frailty Score.
时间窗: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Change from baseline, score based on a 4-point scale.
Change in 6-minute walk test (6-MWT).
时间窗: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Change from baseline in metres (m).
Change in fatigue level.
时间窗: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Change from baseline, score based on a 13 point scale.
Change in quality of life (QOL).
时间窗: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Change from baseline, score based on a 25 question survey.
次要结局
- Participant adherence to a tailored home-based exercise program.(From date of randomization until the date of kidney transplantation, assessed up to 24 months.)
研究者
Christopher Nguan
Associate Professor - UBC Department of Urologic Sciences. Program Director - UBC Urology Postgraduate Education. Surgical Director - Kidney Transplant Program, Vancouver General Hospital
University of British Columbia