Recruiting

Prehabilitation Exercise

Sponsor:

University of British Columbia

Code:

NCT04044963

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Exercise and Prehabilitation

Study Details

Brief summary:

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.

Conditions

End Stage Renal Disease

Study ID

NCT04044963

Start date

Aug 27, 2019

Status verified date

May, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ability to physically participate in a home-based prehabilitation program and all functional outcome measures
2. Ability to read and write in English to respond to study questionnaires
3. Age = to or > 19 and any gender
4. Receiving care at Vancouver General Hospital or St. Paul's Hospital
5. Has been fully worked up for suitability for renal transplantation
6. Received physician clearance to participate

Exclusion Criteria:

1. Unstable pulmonary or symptomatic cardiac disease
2. 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Exercise and Prehabilitation

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.

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. ]
  • Change in 30-second timed sit to stand. [ Time Frame: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant. ]
  • Change in Fried Frailty Score. [ Time Frame: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant. ]
  • Change in fatigue level. [ Time Frame: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant. ]
  • Change in quality of life (QOL). [ Time Frame: Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant. ]
  • Time to first ambulation following kidney transplantation. [ Time Frame: One week following kidney transplant. ]
  • Time to first bowel movement following kidney transplantation. [ Time Frame: One week following kidney transplant. ]
  • Change in number of participants with post operative complications. [ Time Frame: Change from 1 week following kidney transplant to 30 and 90 days post operatively. ]
  • Length of hospital stay following kidney transplantation. [ Time Frame: One week following kidney transplant. ]

Central Contacts and Locations

Central contacts

Christopher Nguan, MD

6048755961chris.nguan@ubcurology.com

Colin E Davey, Mkin

7789951193colin.davey@alumni.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V6N2A2

Contacts

Steven Tang, MSc

6048754111steven.tang@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • Renal transplantation
  • Prehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-16.