OPERATe trial
Research type
Research Study
Full title
Outcomes of a Pre-operative Exercise Regimen for patients undergoing hand-assisted live donor nephrectomy And kidney Transplantation (OPERATe)
IRAS ID
316796
Contact name
Gareth Kitchen
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The main aim of this study is to evaluate the effectiveness of a 6 week pre-operative graded exercise regimen monitored by outpatient wearable technology in improving outcomes for adult, live donor kidney transplant pairs (donor and recipient). It is an initial study looking at the feasibility of these patients engaging with an exercise regimen whilst being monitored 24/7 with wearable technology.
Pre-operative exercise regimens (pre-habilitation) have been shown to reduce complications and improve outcomes in general surgical patients. However, there is little research specifically exploring the impact of these pre-habilitation regimens on a kidney transplant patient cohort. Therefore this study will investigate the role of a pre-operative exercise programme in kidney transplant patients to improve surgical outcomes.
The study will be carried out at Manchester Royal Infirmary Hospital and a total of 20 participants (10 donor pairs) will be recruited. English-speaking adults who are able to engage with exercise and have access to a smart device will be eligible. They will follow a 6 week at-home/gym pre-operative exercise regimen and will be continuously monitored using wearable technology (either an Oura ring, Withings watch or Corsano wristband). These devices measure activity and temperature continuously and collect more detailed measurements of cardiorespiratory fitness during the night. After their transplant participants will continue to wear their device for 6 weeks to obtain vital signs data during their recovery. Participants will be involved for a maximum of 14 weeks.
Measured outcomes will include post-operative kidney function, complication rates and patient survival. Biometric data from the wearable will also be analysed. Feasibility will be assessed from patient compliance to, and experience of the exercise programme and wearing of the wearable. This study will provide critical preliminary data and methodical experience that would inform larger scale intervention trials or fundamental research.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0268
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion