Preoperative Exercise for Patients Undergoing Complex Cancer Surgery

NCT03978325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-04-13

No results posted yet for this study

Summary

Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period.

This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery.

Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.

Conditions

  • Postoperative Complications
  • Physical Activity
  • Surgery--Complications

Interventions

OTHER

Control

The control group will receive standard pre-operative care. This involves standard pre-operative advice and a moderate intensity preoperative exercise programme.

OTHER

Exercise - HIIT Intervention

The HIIT intervention will take the form of a supervised programme, completed for at least two weeks, up to 5 days per week preoperatively. The HIIT intervention will be performed on a cycle ergometer. Exercise sessions will be individually supervised and scheduled at a time of convenience for each participant. Each exercise session will last 40 minutes and will include warm-up, exercise training and cool-down components. Lactate threshold, measured during the baseline CPT, will be used to determine the exercise intensity. The training protocol will prescribe 15 second intervals of exercise and passive recovery. The highest resistance reached during the baseline CPET (measured in watts) will be recorded as the peak power output (PPO). During training, participants will undergo a 5-minute warm-up at 50% PPO, followed by up to 30 minutes of HIIT with intervals of 15 seconds at 100% PPO with 15 second recovery periods at 0 watts.

Sponsors & Collaborators

  • Health Research Board, Ireland

    collaborator OTHER
  • Irish Cancer Society

    collaborator OTHER
  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Juliette Hussey, PhD · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978325 on ClinicalTrials.gov