Preoperative High Intensity Interval Training: The PHIIT Trial

NCT02674815 | Completed

• 1 other identifier: CRFSJ0086
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome including complications, mortality and increased length of stay. Preoperative physical fitness is protective against poor postoperative outcome in intra-abdominal and thoracic surgery. The current colorectal/thoracic pathway from diagnosis to surgery is about 2 weeks and therefore interventions of longer duration are not feasible. Clinicians may be presented with a difficult choice in delaying surgery to perform prehab or cancel the pre-op intervention. To create greater improvements in aerobic fitness, participants are required to exercise at high levels of VO2peak (e.g. ≥80% VO2peak). High intensity interval training (HIIT) requires participants to exercise at high levels of VO2peak (≥80% VO2peak) for short periods (e.g. 15 seconds) followed by a recovery (active or passive) and typically continue this pattern for 30 minutes or until exhaustion. HIIT programmes are safe and a recent meta-analysis noted that HIIT produced a more pronounced incremental gain in participants' mean VO2peak when compared with continuous moderate intensity exercise (+1.78mL/kg/min, 95% CI: 0.45-3.11). HITT has not been investigated as a preoperative intervention to either optimize fitness prior to surgery or reduce post-surgical complications. Preoperative HIIT is an intense intervention which will require significant participant adherence. The safety, cost and clinical application of such a programme needs to be performed. This feasibility study aims to assess the ability of HIIT to improve aerobic fitness two weeks prior to surgery and determine its feasibility.

Conditions

Colorectal Neoplasms; Lung Neoplasms

Keywords

Exercise; Preoperative; High Intensity Interval Training; Colorectal; Thoracic; Postoperative

Outcome Measures

Primary Outcomes (7)

• Cost

  The cost of the programme will be recorded. Expected costs include, parking, room rental charges, equipment rates, employee rates.

  6 months

• Adherence/Compliance

  The adherence rates will be measured by recording the number of appointments each participant attends. The number of missed sessions per participant and the reasons for missing sessions will be recorded and reported. If a participant misses an exercise sessions they will be contacted by the research team to determine the reason and to reschedule the class for later that day if possible. If a participant misses more than 50% of total exercise sessions in the absence of a defined reason (acute illness or scheduled holiday), it will be recorded as a protocol violation.

  6 months

• Incidence of Adverse Events

  Adverse events will be assessed at every clinic visit and the following details recorded: type, incidence, severity, timing, seriousness, and relatedness to a) disease and b) the intervention.

  6 months

• Satisfaction/Acceptability

  Self-administered questionnaire on completion of programme will be administered. Participants will also be asked to highlight what they liked and didn't like about the programme and any suggestions for change.

  6 months

• Withdrawal of participants

  Participants are free to withdraw from the trial at any stage without providing a reason and without consequence. This information will be stated in the participant information leaflet. Participants can inform the research team at their local site of their decision to withdraw. If a participant withdraws from the study, any data collected on them up to that point in the study will go forward for study analysis. This information will be stated in the participant information leaflet. If a participant withdraws from the intervention, but provides consent to complete subsequent follow-up measurements they will continue to attend study assessments and data will be used for intention-to-treat analysis. Participants will be asked for their reason to withdrawing consent, participants are not required to give a reason. Reasons for stopping the intervention will be recorded and reported

  6 months

• Protocol deviations/Adaptations

  The following deviations will be recorded and reported. • Changes to exercise protocol (e.g. reduction in number of sessions, change in % PPO performed during exercise session)

  6 months

• Compliance

  Compliance will be measured in the percentage of exercise sessions attended and successfully completed.

  6 months

Secondary Outcomes (8)

• Postoperative mortality

  Up to day 30 post-op

• Changes in Aerobic Capacity

  6 months

• Length of stay

  6 months

• Postoperative complications assessed using the Postoperative Morbidity Survey

  Up to 7 days post-op

• Readmission rates

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Patients within this arm will perform two weeks of high intensity interval training prior to colorectal/thoracic surgery. Exercise intensity will be 100% of the peak power output (PPO) during maximal cardiopulmonary exercise testing. Patients will exercise for 15 seconds at 100% PPO and rest for 15 seconds (passive) for 30 minutes or until exhaustion. This will be performed 5 days a week for 2 weeks.

Other: High Intensity Interval Training Exercise programme

Interventions

High Intensity Interval Training Exercise programme OTHER

High intensity interval training (HIIT) requires participants to exercise at high levels of VO2peak (≥80% VO2peak). Participants exercise for short periods (e.g. 15-30 seconds) followed by periods of rest (active or passive) and typically continue this pattern for a set time period or until exhaustion.

Also known as: HIIT

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for colorectal or thoracic surgery
• Able to give informed consent
• Ability to understand English

You may not qualify if:

• Acute myocardial infarction
• Unstable angina
• Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
• Syncope
• Active endocarditis
• Symptomatic severe aortic stenosis
• Uncontrolled heart failure
• Acute pulmonary embolous or pulmonary infarction
• Thrombosis of lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Room air desaturation at rest ≤85%
• Respiratory failure
• Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

St. James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 5, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

IE (1)