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Testing Exercise and Prehabilitation for end stage renal disease

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

Condition: End Stage Renal DiseaseSponsor: University of British ColumbiaTarget enrollment: 150
  • 2 groups
  • One site, in Vancouver
  • Recruiting
Vancouver General Hospital, Vancouver, British Columbia

Interventions

  • Behavioural therapy

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia

    Recruiting

Eligibility Criteria

See who this study is looking for9 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Ability to physically participate in a home-based prehabilitation program and all functional outcome measuresEndpointThe specific thing a study measures to answer its question.Read more →
  • +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

  • Unstable pulmonary or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes the ability to exercise
  • \. Is unable to understand the purpose of the study, or cannot give written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to improve comfort and quality of life alongside other care.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Exercise and Prehabilitation.

Registry label: A: Exercise Group

Group B receives no study treatment and is followed for comparison.

Registry label: B: Control Group

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 19 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 150 people.

The study is currently expected to finish around September 2026.

The main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in 6-minute walk test (6-MWT) — measured over Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 — measured over 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 — measured over 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 — measured over 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 5 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04044963 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 19 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 19 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 1 week prior to renal transplantation. Again, change from 1 month post transplant to 6 month post transplant..

The study as a whole is currently expected to finish around 2026-09.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 150 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Vancouver, British Columbia, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.