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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and Prehabilitation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease focused on measuring Renal transplantation, Prehabilitation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

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.

This will consist of regular care, which is standard procedure.

Outcomes

Primary Outcome Measures

Change in 6-minute walk test (6-MWT).
Change from baseline in metres (m).
Change in 30-second timed sit to stand.
Change from baseline in number of repetitions completed in 30 seconds.
Change in Fried Frailty Score.
Change from baseline, score based on a 4-point scale.
Change in fatigue level.
Change from baseline, score based on a 13 point scale.
Change in quality of life (QOL).
Change from baseline, score based on a 25 question survey.
Time to first ambulation following kidney transplantation.
Assessed in days.
Time to first bowel movement following kidney transplantation.
Assessed in days.
Change in number of participants with post operative complications.
Number of participants with post operative complications as assessed by Clavien-Dindo classification.
Length of hospital stay following kidney transplantation.
Assessed in days.

Secondary Outcome Measures

Participant adherence to a tailored home-based exercise program.
Exercise tracker questionnaire. Adherence will be calculated based on a 4 point scale assessing frequency, intensity, time and type of exercise.

Full Information

First Posted
July 31, 2019
Last Updated
November 3, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04044963
Brief Title
The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
Official Title
The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 Baseline Assessment: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP), Quality of Life Survey, Fatigue Survey, Baseline Exercise Level Questionnaire Every 3 Months Leading Up to Renal Transplant: I.e. 3-month, 6-month, 9-month, 12-month post baseline assessment - Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP), Quality of Life Survey, Fatigue Survey One-week Prior to Renal Transplant: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP), Quality of Life Survey, Fatigue Survey Two Day Post Operation: Patient Reported Outcomes - Post-op recovery survey Five Day Post Operation: Patient Reported Outcomes - Post-op recovery survey One Week Post Operation: Patient Reported Outcomes - Post-op recovery survey, Fatigue survey Two Week Post Operation: Patient Reported Outcomes - Post-op recovery survey, Fatigue survey One Month Post Operation: Patient Reported Outcomes - Post-op recovery survey, Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP), Quality of Life Survey, Fatigue Survey Two Month Post Operation: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP) Three Month Post Operation: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP) Four Month Post Operation: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP) Five Month Post Operation: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP) Six Month Post Operation: Physical Fitness assessment (6-MWT, 30-sec sit to stand, Fried Frailty Score, HR+BP), Quality of Life Survey, Fatigue Survey Following the baseline assessment, participants will be randomly allocated to treatment groups (2:1) to a 1) home-based training program (exercise group) and a 2) control group (no prehab just regular care, which is standard procedure). This random allocation will occur via a computer-generated randomized scheme. Following enrolment, each participant allocated to the exercise group will begin the prehabilitation protocol shortly after the initial consultation with their attending urologist. The prehabilitation protocol will be performed from this initial consult up until the date of the scheduled KT (minimum 4 weeks). In person instruction, from a member of the research team with standard first aid and cardiopulmonary resuscitation (CPR) training, and an instructional handout and exercise log will be provided, as well as exercise resistance bands to perform resistance exercises. The exercise log will be given to each study participant and will be used solely as a method to make organizing and recording each exercise session easier for the participant. The exercise log will not be collected by the study team. The exercise log should be completed following each exercise session and it should take no longer than 2-3 minutes to complete. 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. Aerobic Component: 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. Initially, the patient may start with 10 minutes, three times a week. Slowly progressing first with duration (10 to 15 min), followed by an increase in exercise intensity (increased speed or grade - RPE from 3 - 5). Resistance Component: 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. Initially, the patient may start with 8 repetitions and 1 set and progress to a maximum of 12 repetitions and 3 sets. If a participant is able to complete >12 repetitions and 3 sets of a specific resistance exercise than they will increase resistance (i.e. green band to red band). These exercises will be provided in the handout that each participant will receive. Lower body exercises will include foot, knee and hip flexion and extension, and hip adduction and adduction. Upper body exercises will include arm and wrist flexion and extension, and shoulder abduction and adduction. Flexibility Component: The flexibility component will include 5 exercises that can be completed at the end of each session. This should take no longer than 5-10 minutes. These exercises will be provided in the handout that each participant will receive. Flexibility exercises will include a hamstring stretch, quadriceps stretch, hip external rotation, standing lumbar extension, and upper body shoulder and arm stretch. Participants will self-report their participation in the prehabilitation program based on an electronic survey. The intent of the survey is to follow the frequency, time and type of exercise of the patient leading up to the operation and identify whether the patient is adhering to the exercise intervention. The survey will take an estimated 3-5 minutes to complete and will primarily consist of Likert-scale questions and checkboxes. Survey responses will be stored on University of British Columbia (UBC) owned and operated servers such as the Qualtrics tool supported and maintained by UBC IT. Self-reported exercise and physical measures will be recorded at baseline, and every two or three weeks prior to each patients KT as well as bi-weekly post-operatively up until 1-month post KT. This confidential, anonymized, electronic pre-operative survey will be used to keep track of self-reported physical activity levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Renal transplantation, Prehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This will consist of regular care, which is standard procedure.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Prehabilitation
Intervention Description
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 Information:
Title
Change in 6-minute walk test (6-MWT).
Description
Change from baseline in metres (m).
Time Frame
Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Title
Change in 30-second timed sit to stand.
Description
Change from baseline in number of repetitions completed in 30 seconds.
Time Frame
Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Title
Change in Fried Frailty Score.
Description
Change from baseline, score based on a 4-point scale.
Time Frame
Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Title
Change in fatigue level.
Description
Change from baseline, score based on a 13 point scale.
Time Frame
Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Title
Change in quality of life (QOL).
Description
Change from baseline, score based on a 25 question survey.
Time Frame
Change from baseline to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.
Title
Time to first ambulation following kidney transplantation.
Description
Assessed in days.
Time Frame
One week following kidney transplant.
Title
Time to first bowel movement following kidney transplantation.
Description
Assessed in days.
Time Frame
One week following kidney transplant.
Title
Change in number of participants with post operative complications.
Description
Number of participants with post operative complications as assessed by Clavien-Dindo classification.
Time Frame
Change from 1 week following kidney transplant to 30 and 90 days post operatively.
Title
Length of hospital stay following kidney transplantation.
Description
Assessed in days.
Time Frame
One week following kidney transplant.
Secondary Outcome Measure Information:
Title
Participant adherence to a tailored home-based exercise program.
Description
Exercise tracker questionnaire. Adherence will be calculated based on a 4 point scale assessing frequency, intensity, time and type of exercise.
Time Frame
From date of randomization until the date of kidney transplantation, assessed up to 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Nguan, MD
Phone
6048755961
Email
chris.nguan@ubcurology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Colin E Davey, Mkin
Phone
7789951193
Email
colin.davey@alumni.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Nguan, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6N2A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Tang, MSc
Phone
6048754111
Ext
62337
Email
steven.tang@ubc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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