NCT04047524

A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shira Baram · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prehabilitation programmes have the potential to reduce post-operative complications following abdominal cancer surgery by improving pre-operative fitness levels. Home-based prehabilitation programmes may be more cost effective than hospital-based programmes, but have issues with low compliance. The aims of our study are to assess whether mobile technologies such as smart watches and smartphone applications improve compliance with home-based prehabilitation programmes and to assess the effects of prehabilitation on pre-operative fitness levels in patients due to undergo major abdominal cancer surgery.

Detailed description

30 patients due to undergo major abdominal cancer surgery at The Christie NHS Foundation Trust will be enrolled to a pilot randomised controlled trial. They will randomised to either a home-based trimodal prehabilitation programme, delivered by the use of FitBit Smart Watches and Smartphone applications, or a control group who will receive a FitBit for physical activity monitoring only, for a period of 2-6 weeks prior to surgery. The prehabilitation programme will include exercise, nutritional, and psychological components. Study outcomes will include 6MWT (6-minute walk test), HADS (hospital anxiety and depression score), steps per day, length of stay post-operatively, and post-operative complications.

Conditions

• Pilot Study

Interventions

Type	Name	Description
OTHER	Monitoring using a FitBit	Each participant will receive a Fitbit. The Prehabilitaiton Group will receive a Fitbit Charge 2 and they will be able to review their progress on this and be required to increase their exercise activity and input information and data about the exercise they have completed each day during their participation in the study. The Control group will receive a Fitbit Flex and will not be required to review any of their activity or input any data and will be encouraged to continue with their daily activity rates i.e. not to change.

Timeline

• Start date: 2019-05-14
• Primary completion: 2019-12-28
• Completion: 2019-12-28
• First posted: 2019-08-06
• Last updated: 2019-08-20

Locations

1 site across 1 country: United Kingdom