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A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047524
Recruitment Status : Unknown
Verified August 2019 by Shira Baram, University of Manchester.
Recruitment status was:  Recruiting
First Posted : August 6, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
Shira Baram, University of Manchester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pilot Study Other: Monitoring using a FitBit Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants will be randomised sequentially i.e. 1:1 to receive either the Prehabilitation Programme or not
Masking: None (Open Label)
Masking Description: There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
Primary Purpose: Basic Science
Official Title: Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2019
Arms and Interventions
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Arm Intervention/treatment
Prehabilitation
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
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
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Quantitative data collected via a Fitbit [ Time Frame: 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 :
  1. Qualitative data collected by questionnaire [ Time Frame: 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

  2. Quantitative data associated with participants weight at the start and end of the research intervention [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047524


Contacts
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Contact: Shira Baram 0161 918 2098 shira.baram@christie.nhs.uk

Locations
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United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Shira Baram    01619182098    shira.baram@christie.nhs.uk   
Sponsors and Collaborators
Shira Baram
The Christie NHS Foundation Trust
Investigators
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Principal Investigator: Omer Aziz The Christie NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shira Baram, Research Project Manager, University of Manchester
ClinicalTrials.gov Identifier: NCT04047524    
Other Study ID Numbers: 19_SURG_19
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not currently be shared with researchers outside of the study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No