Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients

NCT ID: NCT06858098

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn if a pre-operative outpatient exercise programme, monitored by a smart wearable device is acceptable to live kidney donor and recipient transplant patients. It will also look at the impact of prehabilitation on post operative outcomes. The main questions it aims to answer are:

Is it feasible for renal transplant patients and live kidney donors to participate in a prehabilitation programme in combination with a piece of wearable technology?

Are transplant outcomes improved by prehabilitation regimens delivered by video instruction?

Are there discernible perioperative digital signatures provided by the wearable that link to surgical outcomes?

Is the quality of perioperative sleep linked to surgical outcomes?

Participants will:

Wear a wrist or ring worn wearable device for a total of 14 weeks (2 week baseline, 6 week pre op and 6 week post op) Engage in a 6 week pre operative exercise programme at home/gym Keep a diary and answer surveys on their experience of the exercise regimen and wearable device

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant Kidney Transplant Donor Kidney Transplant Recipient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Entire cohort

All participants (both transplant donor and recipients) will be assigned a 6 week graded pre operative outpatient exercise regimen (prehabilitation) delivered by video instruction. Participants will also be monitored 24/7 by a wearable smart device for a total 14 week period (2 week baseline data collection, 6 weeks during prehabilitation and 6 weeks post op).

Group Type EXPERIMENTAL

Exercise programme

Intervention Type OTHER

6 week pre-operative graded prehabilitation programme, delivered by video and performed by participant up to 4 times a week at home or in a gym setting

Wearable smart device

Intervention Type DEVICE

Participants will wear a wearable smart device (wrist or ring worn) for a period for 14 weeks; 2 weeks prior to prehabilitation, 6 weeks during pre-operative prehabilitation and 6 weeks post operative monitoring,

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise programme

6 week pre-operative graded prehabilitation programme, delivered by video and performed by participant up to 4 times a week at home or in a gym setting

Intervention Type OTHER

Wearable smart device

Participants will wear a wearable smart device (wrist or ring worn) for a period for 14 weeks; 2 weeks prior to prehabilitation, 6 weeks during pre-operative prehabilitation and 6 weeks post operative monitoring,

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 years and over
* Live kidney donor or transplant recipient

Exclusion Criteria

* Deceased donor transplant recipient
* Patient unable to wear or tolerate wearable device
* Unstable angina, recent myocardial infarction, recent cerebrovascular accident or new arrythmia
* Patient declines or is unable to participate in the exercise programme
* Lacks capacity to give informed consent to participate in trial
* Non-English speaking
* No access to a smart device to download application
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gareth Kitchen

Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gareth Kitchen

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Hussein Khambalia

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gareth Kitchen

Role: CONTACT

+447977280019

Sophie Collinson

Role: CONTACT

+447766827099

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hussein Khambalia

Role: primary

Sophie Collinson

Role: backup

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

316796

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Home-based Exercise in Renal Transplant Recipients
NCT04123951 ACTIVE_NOT_RECRUITING NA