Kidney TransplantOPERATeNCT06858098
Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients
A study testing Exercise programme and Wearable smart device in people with Kidney Transplant and Kidney Transplant Donor, run by University of Manchester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Kidney Transplant Donor, Kidney Transplant Recipient
- What is being tested?
- Exercise programme and Wearable smart device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and over
- Live kidney donor or transplant recipient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Manchester Royal Infirmary
Manchester, M13 9WL
Hussein Khambalia, hussein.khambalia@mft.nhs.uk
Sophie Collinson, sophie.collinson1@nhs.net
About this study
Official title: Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation
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?
Read more
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
- Being tested
- Exercise programme, Wearable smart device
- Keywords
- live kidney transplant, prehabilitation, wearable devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeOther
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 deviceDevice
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,
| Study group | Role | What they receive |
|---|---|---|
| Entire cohort | Experimental | 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). Receives: Other: Exercise programme; Device: Wearable smart device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number days exercise regimen performed and wearable device worn
Acceptability of a prehabiltation programme and wearable device. Is a pre-operative exercise regimen, monitored by a wearable smart device acceptable to live kidney donor and recipient transplant patients? Qualitative data collected through patient surveys and journals. Quantitative measures = number of days exercise performed \& number of days wearable device worn
Measured: From enrollment to the end of the study at 14 weeks total
Secondary outcomes (3)
Number of participants with post operative complications
To assess if prehabilitation programmes have a positive effect on surgical outcomes, quantitative data on the rate and type of post operative complications will be recorded at the standard 6 week post operative patient follow up.
Measured: From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up
REM Sleep pattern analysis
To assess if there is a link between perioperative sleep patterns and post surgical complications, retrospective analysis of changes in REM vs Non-REM sleep patterns over the 14 week period will be compared to the incidence of post operative complications. REM vs. non-REM data is measured by the wearable device.
Measured: From enrollment to the end of the study at 14 weeks total when data collection ends
Resting heart rate and heart rate variability
Are there discernible perioperative digital signatures (vital signs) recorded by the wearable device that are linked to post-operative outcomes? Retrospective analysis of changes in resting heart rate and heart rate variability, both associated with physiological fitness, will be performed and compared to the incidence of post surgical complications in individual participants (outcome 2)
Measured: From enrollment to the end of the study at 14 weeks total when data collection ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion28 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Gareth Kitchen, University of Manchester
- Investigators
- Gareth Kitchen, Principal investigator, University of ManchesterHussein Khambalia, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858098
- Sponsor's protocol ID
- 316796
- Acronym
- OPERATe
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation
- ClinicalTrials.gov ID
- NCT06858098
- Acronym / sponsor ID
- OPERATe / 316796
- Keywords
- live kidney transplant, prehabilitation, wearable devices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire cohort | Experimental | Other: Exercise programme, Device: Wearable smart deviceAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years and over
- Live kidney donor or transplant recipient
Key exclusion criteria (7 listed)
- 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
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 programme6 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 | Other | Entire cohort |
| Wearable smart deviceParticipants 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, | Device | Entire cohort |
Primary outcome
Number days exercise regimen performed and wearable device worn
Time frame: From enrollment to the end of the study at 14 weeks total
Acceptability of a prehabiltation programme and wearable device. Is a pre-operative exercise regimen, monitored by a wearable smart device acceptable to live kidney donor and recipient transplant patients? Qualitative data collected through patient surveys and journals. Quantitative measures = number of days exercise performed \& number of days wearable device worn
3 secondary outcomes
Number of participants with post operative complications
Time frame: From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up
REM Sleep pattern analysis
Time frame: From enrollment to the end of the study at 14 weeks total when data collection ends
Resting heart rate and heart rate variability
Time frame: From enrollment to the end of the study at 14 weeks total when data collection ends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Gareth Kitchen principal investigator
University of Manchester
Hussein Khambalia principal investigator
Manchester University NHS Foundation Trust
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 programme and Wearable smart device in people with Kidney Transplant and Kidney Transplant Donor, run by University of Manchester at 1 site in United Kingdom.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gareth Kitchen (+447977280019, gareth.kitchen@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number days exercise regimen performed and wearable device worn (time frame: From enrollment to the end of the study at 14 weeks total). 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 25 Mar 2025.