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A Trimodal Prehabilitation Study for Patients Undergoing Major Abdominal Surgery

S

Shira Baram

Status

Unknown

Conditions

Pilot Study

Treatments

Other: Monitoring using a FitBit

Study type

Interventional

Funder types

Other

Identifiers

NCT04047524
19_SURG_19

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Prehabilitation
Other group
Description:
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.
Treatment:
Other: Monitoring using a FitBit
Control
Other group
Description:
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
Treatment:
Other: Monitoring using a FitBit

Trial contacts and locations

1

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Central trial contact

Shira Baram

Data sourced from clinicaltrials.gov

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