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

NCT04044963 | Recruiting

• 1 other identifier: H19-01405
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Renal transplantation; Prehabilitation

Outcome Measures

Primary Outcomes (9)

• Change in 6-minute walk test (6-MWT).

  Change from baseline in metres (m).

  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.

  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.

  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.

  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.

  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.

  One week following kidney transplant.

• Time to first bowel movement following kidney transplantation.

  Assessed in days.

  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.

  Change from 1 week following kidney transplant to 30 and 90 days post operatively.

• Length of hospital stay following kidney transplantation.

  Assessed in days.

  One week following kidney transplant.

Secondary Outcomes (1)

• Participant adherence to a tailored home-based exercise program.

  From date of randomization until the date of kidney transplantation, assessed up to 24 months.

Study Arms (2)

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.

Behavioral: Exercise and Prehabilitation

Control Group

NO INTERVENTION

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

Interventions

Exercise and Prehabilitation BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 consent

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V6N2A2, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise; Preoperative Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christopher Nguan, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Nguan, MD

CONTACT

6048755961; chris.nguan@ubcurology.com

Colin E Davey, Mkin

CONTACT

7789951193; colin.davey@alumni.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - UBC Department of Urologic Sciences. Program Director - UBC Urology Postgraduate Education. Surgical Director - Kidney Transplant Program, Vancouver General Hospital

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 5, 2019
• Study Start: August 27, 2019
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)