A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

Not Applicable

• Conditions: Pilot Study
• Interventions: Other: Monitoring using a FitBit

• Registration Number: NCT04047524
• Lead Sponsor: Shira Baram

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 Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2019-07-15
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20
• Primary Completion: 2019-12-28
• Study Completion: 2019-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Monitoring using a FitBit	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.
Control	Monitoring using a FitBit	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

Primary Outcome Measures

Name	Time	Method
Quantitative data collected via a Fitbit	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 Outcome Measures

Name	Time	Method
Qualitative data collected by questionnaire	Each participant will be monitored for a period of 2-6 weeks pre surgery	Qualitative data will be collected from participants to identify their experience of the study
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	Participants weight will be measured in kilograms at the start of their participation and then prior to surgery to determine if they were able to either maintain their weight or gain weight

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom