A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

NCT04047524 | Unknown DMC

• 1 other identifier: 19_SURG_19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilot Study

Outcome Measures

Primary Outcomes (1)

• Quantitative data collected via a Fitbit

  Data will be collected to determine the number of participants whose physical activity increased and by how much during the study

  Each participant will be monitored for a period of 2-6 weeks pre surgery

Secondary Outcomes (2)

• 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

Study Arms (2)

Prehabilitation

OTHER

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.

Other: Monitoring using a FitBit

Control

OTHER

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

Other: Monitoring using a FitBit

Interventions

Monitoring using a FitBit OTHER

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.

Control; Prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shira Baram: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33723969 DERIVED

Study Officials

• Omer Aziz

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shira Baram

CONTACT

0161 918 2098; shira.baram@christie.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Project Manager

Model Details: Participants will be randomised sequentially i.e. 1:1 to receive either the Prehabilitation Programme or not

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 6, 2019
• Study Start: May 14, 2019
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)