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| Name | Class |
|---|---|
| The Christie NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative data collected by questionnaire | Qualitative data will be collected from participants to identify their experience of the study | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shira Baram | Contact | 0161 918 2098 | shira.baram@christie.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Omer Aziz | The Christie NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Recruiting | Manchester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33723969 | Derived | 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. |
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Data will not currently be shared with researchers outside of the study team
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Participants will be randomised sequentially i.e. 1:1 to receive either the Prehabilitation Programme or not
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There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
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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 |
| Each participant will be monitored for a period of 2-6 weeks pre surgery |