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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Christopher Nguan, MD contact

6048755961

chris.nguan@ubcurology.com

Colin E Davey, Mkin contact

7789951193

colin.davey@alumni.ubc.ca

Canada1 site, 1 recruiting
  • Vancouver General Hospital

    Vancouver, British Columbia, V6N2A2

    Steven Tang, MSc, 6048754111 ext. 62337, steven.tang@ubc.ca

    Recruiting

Other trials in Canada

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

  1. Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue
  2. 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).
  3. 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.
  4. 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.

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 groups in NCT04044963
Study groupRoleWhat they receive
Exercise GroupExperimentalAll 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 GroupNo interventionThis 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Time to first ambulation following kidney transplantation.

    Assessed in days.

    Measured: One week following kidney transplant.

  7. Time to first bowel movement following kidney transplantation.

    Assessed in days.

    Measured: One week following kidney transplant.

  8. 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.

  9. Length of hospital stay following kidney transplantation.

    Assessed in days.

    Measured: One week following kidney transplant.

Secondary outcomes (1)
  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.

  1. First posted5 Aug 2019
  2. Study start27 Aug 2019
  3. Primary completionJan 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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)
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

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.

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