The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation

Sponsor
University of British Columbia
Study ID
NCT04044963
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise and Prehabilitation — BEHAVIORAL
    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 aerobic component can include any modality the patient is capable of doing, including walking, swimming or biking. By the end of the prehabilitation period the target will be 30 minutes of aerobic exercise three times a week at an intensity of 3-5 RPE. The resistance component will include 5-6 exercises using body weight and resistance bands. The target will be 12 repetitions and 3 sets, two times a week. The flexibility component will include 5 exercises that can be completed at the end of each session. Participants will self-report their participation in the prehabilitation program based on an electronic survey.

Study Details

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.

Key Dates

First listed
Aug 5, 2019
Start date
Aug 27, 2019
Status verified
May 2024
Primary completion
Jan 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: Control Group
    This will consist of regular care, which is standard procedure.

Primary Outcome Measure

Change in 6-minute walk test (6-MWT). [ Time Frame: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant. ]

Central Contacts

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