Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Quantitative data collected via a Fitbit
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •be aged 18 years or over
- •be able to consent to participate in the prehabilitation programme
- •be undergoing major abdominal cancer surgery (including, but not limited to, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy)
- •have at least 2 weeks to their operation date
- •be able to understand written and spoken English
Exclusion Criteria
- •patients have any health conditions which will prevent them from safely taking part in a home-based exercise programme. For example, but not limited to, patients who have recently (within the past 3 months) had a myocardial infarction or a stroke or patients who have end-stage renal disease but are not on dialysis. We will use the "Safety Reference Guide to support exercise services in people with cancer" in The Lancet published paper "Exercise as part of routine cancer care"(5) to aid the screening of patients suitability.
- •they have any bone metastasis
- •are already active users of a FitBit device
Arms & Interventions
Prehabilitation
These participants will receive a home based prehabilitation programme for a period of 2-6 weeks prior to surgery and will be provided with a Fitbit Charge 2.
Intervention: Monitoring using a FitBit (Other)
Control
These participants will receive a Fitbit Flex and told to continue with their every day activity levels for a period of 2-6 weeks prior to surgery
Intervention: Monitoring using a FitBit (Other)
Outcomes
Primary Outcomes
Quantitative data collected via a Fitbit
Time Frame: Each participant will be monitored for a period of 2-6 weeks pre surgery
Data will be collected to determine the number of participants whose physical activity increased and by how much during the study
Secondary Outcomes
- Qualitative data collected by questionnaire(Each participant will be monitored for a period of 2-6 weeks pre surgery)
- Quantitative data associated with participants weight at the start and end of the research intervention(Each participant will be monitored for a period of 2-6 weeks pre surgery)
Investigators
Shira Baram
Research Project Manager
University of Manchester