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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise programme | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of the study at 14 weeks total |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gareth Kitchen | Contact | +447977280019 | gareth.kitchen@manchester.ac.uk | |
| Sophie Collinson | Contact | +447766827099 | sophie.collinson1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Gareth Kitchen | University of Manchester | Principal Investigator |
| Hussein Khambalia | Manchester University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2024 | Feb 13, 2025 |
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| Wearable smart device | 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, |
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| 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. | 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) | From enrollment to the end of the study at 14 weeks total when data collection ends |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2025 | Feb 13, 2025 | ICF_001.pdf |