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

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ClinicalTrials.gov Identifier: NCT04044963
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Nguan, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: Exercise and Prehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
Actual Study Start Date : August 27, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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.


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



Primary Outcome Measures :
  1. 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 from baseline in metres (m).

  2. 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 from baseline in number of repetitions completed in 30 seconds.

  3. 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 from baseline, score based on a 4-point scale.

  4. 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 from baseline, score based on a 13 point scale.

  5. 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. ]
    Change from baseline, score based on a 25 question survey.

  6. Time to first ambulation following kidney transplantation. [ Time Frame: One week following kidney transplant. ]
    Assessed in days.

  7. Time to first bowel movement following kidney transplantation. [ Time Frame: One week following kidney transplant. ]
    Assessed in days.

  8. 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. ]
    Number of participants with post operative complications as assessed by Clavien-Dindo classification.

  9. Length of hospital stay following kidney transplantation. [ Time Frame: One week following kidney transplant. ]
    Assessed in days.


Secondary Outcome Measures :
  1. Participant adherence to a tailored home-based exercise program. [ Time Frame: From date of randomization until the date of kidney transplantation, assessed up to 24 months. ]
    Exercise tracker questionnaire. Adherence will be calculated based on a 4 point scale assessing frequency, intensity, time and type of exercise.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044963


Contacts
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Contact: Christopher Nguan, MD 6048755961 chris.nguan@ubcurology.com
Contact: Colin E Davey, Mkin 7789951193 colin.davey@alumni.ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V6N2A2
Contact: Steven Tang, MSc    6048754111 ext 62337    steven.tang@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Christopher Nguan, MD University of British Columbia

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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT04044963     History of Changes
Other Study ID Numbers: H19-01405
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Nguan, University of British Columbia:
Renal transplantation
Prehabilitation
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency