End Stage Renal DiseaseNCT04044963
The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
A study testing Exercise and Prehabilitation in people with End Stage Renal Disease, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Exercise and Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2019to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V6N2A2
Steven Tang, MSc, 6048754111 ext. 62337, steven.tang@ubc.ca
About this study
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.
Read more
Objectives
- Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue
- 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).
- 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.
- Quantify the differences described above, if any exist.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Exercise and Prehabilitation
- Keywords
- Renal transplantation, Prehabilitation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and PrehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 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. Receives: Behavioral: Exercise and Prehabilitation |
| Control Group | No intervention | This will consist of regular care, which is standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk test (6-MWT).
Change from baseline in metres (m).
Measured: 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.
Change from baseline in number of repetitions completed in 30 seconds.
Measured: 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.
Change from baseline, score based on a 4-point scale.
Measured: 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.
Change from baseline, score based on a 13 point scale.
Measured: 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).
Change from baseline, score based on a 25 question survey.
Measured: 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.
Assessed in days.
Measured: One week following kidney transplant.
Time to first bowel movement following kidney transplantation.
Assessed in days.
Measured: One week following kidney transplant.
Change in number of participants with post operative complications.
Number of participants with post operative complications as assessed by Clavien-Dindo classification.
Measured: Change from 1 week following kidney transplant to 30 and 90 days post operatively.
Length of hospital stay following kidney transplantation.
Assessed in days.
Measured: One week following kidney transplant.
Secondary outcomes (1)
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.
Measured: From date of randomization until the date of kidney transplantation, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start27 Aug 2019
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Nguan, University of British Columbia
- Investigators
- Christopher Nguan, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044963
- Sponsor's protocol ID
- H19-01405
- Status last verified
- May 2024
- First submitted
- 31 Jul 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04044963
- Acronym / sponsor ID
- H19-01405
- Conditions
- End Stage Renal Disease
- Keywords
- Renal transplantation, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise and PrehabilitationAll 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. |
| Control Group | No intervention | –This will consist of regular care, which is standard procedure. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and PrehabilitationAll 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. | Behavioural | Exercise Group |
Primary outcome
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).
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.
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.
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.
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.
Time to first ambulation following kidney transplantation.
Time frame: One week following kidney transplant.
Assessed in days.
Time to first bowel movement following kidney transplantation.
Time frame: One week following kidney transplant.
Assessed in days.
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.
Length of hospital stay following kidney transplantation.
Time frame: One week following kidney transplant.
Assessed in days.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Nguan, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Prehabilitation in people with End Stage Renal Disease, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Nguan, MD (6048755961, chris.nguan@ubcurology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.