A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

Pilot Study Clinical Trial

Official title:

Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047524
• Other study ID #: 19_SURG_19
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: December 28, 2019

Study information

• Verified date: August 2019
• Source: University of Manchester
• Contact: Shira Baram
• Phone: 0161 918 2098
• Email: shira.baram[@]christie.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilot Study

Intervention

Other:
• Monitoring using a FitBit
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.

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Shira Baram	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quantitative data associated with participants weight at the start and end of the research intervention	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