Clinical trial NCT04047524: A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery
Official title: Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilot Study
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2019-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants will be randomised sequentially i.e. 1:1 to receive either the Prehabilitation Programme or not
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantitative data collected via a Fitbit
timeFrame: Each participant will be monitored for a period of 2-6 weeks pre surgery
Secondary outcomes:
measure: Qualitative data collected by questionnaire
timeFrame: Each participant will be monitored for a period of 2-6 weeks pre surgery
measure: Quantitative data associated with participants weight at the start and end of the research intervention
timeFrame: Each participant will be monitored for a period of 2-6 weeks pre surgery
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Omer Aziz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waller E, Sutton P, Rahman S, Allen J, Saxton J, Aziz O. Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). Surg Endosc. 2022 Feb;36(2):1008-1017. doi: 10.1007/s00464-021-08365-6. Epub 2021 Mar 15.