Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers

NCT06071650 | Unknown

• 1 other identifier: 308356
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness, which leads to improved outcomes of surgery. This service is now being run remotely, however, there is little existing evidence to support the best practice for this. Currently, baseline fitness is assessed remotely using either a sit to stand test or a step test. Once completed people are prescribed regular exercises and asked to exercise to a level of intensity using a measure called Rating of Perceived Exertion (RPE). However, these measurements may not be reliable. We are carrying out a study to assess if another waking test (modified Rockport test) and asking patients to exercise to a target heart rate are better measures of assessing baseline fitness and exercise intensity. All participants will receive weekly telephone calls to check their progress and be provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to one of two groups. The only difference between the groups will be the way the exercise is prescribed. In one group participants will be asked to complete the exercises to an exercise level they find "somewhat hard". The other group will be asked to complete the exercises to maintain a set heart rate. All participants will be asked to complete an activity log (submitted weekly) as an online form. A small group of people (maximum 10) will be asked if they would like to complete an in-person baseline fitness assessment also, this is optional. This study runs for up to eight weeks with participation ending after eight weeks or at the time of surgery, whichever is sooner. In the final week of participation, participants will be asked to complete an online questionnaire about their experience of using a wearable fitness tracker during the prehabilitation programme.

Conditions

Cancer

Keywords

preoperative exercise; prehabilitation; activity tracker; kinesiotherapy

Outcome Measures

Primary Outcomes (1)

• Total number of minutes of moderate intensity exercise

  The primary outcome will compare between intervention and control groups the total number of minutes of moderate intensity exercise, i.e., exercise within target range as measure on the Fitbit over the 8 weeks of follow-up

  Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.

Secondary Outcomes (7)

• Volume of physical activity (mean MET min/week) achieved.

  Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.

• Weekly adherence (mean percentage of actual/prescribed MET minutes/week)

  Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.

• Duration of exercise self-reported vs recorded HR data (minutes)

  Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.

• Intensity of exercise self-reported vs recorded HR data (RPE vs % of target HR zone)

  Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.

• Patient feedback of using heart rate trackers in a prehabilitation setting - Technology acceptance Model (TAM)

  Questionnaire collected from each participant at the end of their heart rate data collection (after 8 weeks or until they have undergone their cancer resection)

Study Arms (2)

Group A - Exercise to Rating of Perceived Exertion (RPE) - "Control Group"

NO INTERVENTION

Participants prescribed moderate intensity aerobic exercise using their rating of perceived exertion (RPE) with a goal of sustaining an intensity level of 12 to 14 for their prescribed duration.

Group B - Exercise to a Heart Rate (HR) Zone - "Intervention Group"

EXPERIMENTAL

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration.

Behavioral: Exercise to a Heart Rate (HR) Zone

Interventions

Exercise to a Heart Rate (HR) Zone BEHAVIORAL

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration

Group B - Exercise to a Heart Rate (HR) Zone - "Intervention Group"

Eligibility Criteria

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

You may qualify if:

• Age 18 - 80 years.
• New diagnosis of non-metastatic oesophago-gastric (OG), hepatobiliary (HPB) or Lung Cancer (LC) being offered surgical resection with curative intent at Imperial College NHS Healthcare Trust (OG/HPB) or Guy's and St Thomas' Hospital (LC).
• Proficient in English
• Enrolled in a prehabilitation programme.
• Capable of providing informed consent and willing to comply with all parts of the protocol.

You may not qualify if:

• Unable to provide informed consent.
• Non-resectable disease.
• Declined surgery.
• No access to smart phone/tablet or internet
• Involved in other current research or have recently been involved in any research prior to recruitment

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Krishna Moorthy

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigel JM Noor, MBChB

CONTACT

07905000796; Nigel.Noor@nhs.net

Becky Ward

CONTACT

0207 594 9459; becky.ward@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the study and the interventions offered, it will not be possible to blind participants or research assistants to allocation groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, two-arm randomised parallel group clinical trial. Prehabilitation is routinely offered as the standard of care to all patients who are scheduled for curative resectional surgeries for upper gastrointestinal (UGI) cancer at Imperial College Healthcare Trust and lung cancer at Guy's and St Thomas' NHS Foundation Trust. Consecutive patients referred for prehabilitation will be approached for enrolment into the study. If willing to participate, written informed consent will be gained (e-consent). Following enrolment all participants will be provided with a wearable fitness tracker and will be randomised to one of two groups (1:1 randomisation) - Group A or Group B. The only difference between the two groups is the prescription of exercise, all other activities and data collected are the same. Randomisation following recruitment and using a computer programme.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: October 6, 2023
• Study Start: February 27, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)