Colorectal NeoplasmsPHIITNCT02674815
Preoperative High Intensity Interval Training: The PHIIT Trial
A study testing High Intensity Interval Training Exercise programme in people with Colorectal Neoplasms and Lung Neoplasms, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Lung Neoplasms
- What is being tested?
- High Intensity Interval Training Exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for colorectal or thoracic surgery
- Able to give informed consent
- Ability to understand English
Who cannot join
- Acute myocardial infarction
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Active endocarditis
- Symptomatic severe aortic stenosis
Show all 31Show fewer
- 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)
- Cognitive impairment leading to inability to cooperate
- Left main coronary stenosis or equivalent
- Moderate stenotic valvular heart disease
- Severe untreated arterial hypertension at rest (>200 mmHg systolic, >120 mmHg diastolic)
- Tachyarrhythmias or bradyarrhythmias
- High-degree atrioventricular block
- Hypertrophic cardiomyopathy
- Significant pulmonary hypertension
- Pregnancy
- Electrolyte abnormalities
- Orthopaedic impairment that compromises exercise performance
- Individuals with pacemakers or defibrillators
- Epilepsy
- Past history or MRI evidence of brain damage, including significant trauma, stroke, transient ischaemic attack (TIA), hydrocephalus, mental retardation, or serious neurological disorder
- Non resectable disease
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative High Intensity Interval Training in Patients Scheduled for Colorectal and Thoracic Surgery: The PHIIT Trial
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.
Read more
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.
Read the detailed description
Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome. In colorectal surgery the rate of post-op complications is between 15-20% and the rate of 30 day mortality is 2.3%. Thoracic surgery also carries significant risk, 30 day mortality is 2.2% while the rate of post-op complications is 29.3%. Poor postoperative outcome significantly affects the patients recovery and increases hospital costs. Reducing postoperative risk therefore conveys significant benefit to the patient and the hospital.
Preoperative physical fitness is predictive of postoperative outcome in intra-abdominal and thoracic surgery. In a systematic review of 6 studies preoperative exercise interventions improved pre-op physical fitness in patients undergoing abdominal surgery, however it is unclear if this translates into an improvement in postoperative outcome.
An updated systematic review and meta-analysis was performed on the effects of pre-habilitation on postoperative outcome. While the results demonstrated that preoperative exercise interventions of 4-6 week duration reduced post-op complications a significant amount of work is still to be performed in this area.
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). Participants exercise for short periods (15 seconds) followed by 15 seconds of rest and typically continue this pattern for 30 minutes or until exhaustion.
A recent review reported HIIT programmes to be safe in individuals with coronary artery disease and stable heart failure. In agreement with this paper a recent meta-analysis noted that HIIT produced a more pronounced incremental gain in participants' mean VO2peak when compared with continuous moderate intensity exercise There are a number of factors to take into account when designing a HIIT programme e.g. duration and intensity of exercise phase and type of recovery period (active vs. passive). Two papers compared a selection of HIIT protocols for safety and time at a high percentage of VO2peak (≥ 80% VO2peak). Protocols with rest periods (passive recovery) allowed patients to exercise for longer and had lower perceived difficulties. In one study of 20 patients with CAD, HITT was prescribed with 15s exercise and passive recovery intervals at 100% Peak Power Output (PPO) or Maximal Aerobic Power (MAP) with no adverse events. PPO or MAP is the power of the last completed stage during a maximal exercise test (watts). This intervention had the highest duration above 80% VO2peak (819s) and a high completion rate of 63%. This protocol was chosen for this study.
HITT has not been investigated as a preoperative intervention to either optimize fitness prior to surgery or reduce postsurgical 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
- Being tested
- High Intensity Interval Training Exercise programme
- Keywords
- Exercise, Preoperative, High Intensity Interval Training, Colorectal, Thoracic, Postoperative
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training Exercise programmeOther
Also called HIIT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: High Intensity Interval Training Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost
The cost of the programme will be recorded. Expected costs include, parking, room rental charges, equipment rates, employee rates.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 6 months
Compliance
Compliance will be measured in the percentage of exercise sessions attended and successfully completed.
Measured: 6 months
Secondary outcomes (8)
Postoperative mortality
Postoperative mortality will be recorded until day 30 post-op.
Measured: Up to day 30 post-op
Changes in Aerobic Capacity
Participants will perform a maximal CPET prior to beginning of intervention to establish baseline aerobic fitness. Upon completion of the intervention, prior to surgery, participants will repeat the maximal CPET.
Measured: 6 months
Length of stay
Length of stay will include general hospital stay from time of operation to discharge, ICU/HDU admission rates and length of stay as well as readmission rates.
Measured: 6 months
Postoperative complications assessed using the Postoperative Morbidity Survey
Postoperative morbidity will be assessed using the postoperative morbidity survey (POMS) (type and number of complications on a specific day). POMS will be performed on Day 3, 5, 6 and 7.
Measured: Up to 7 days post-op
Readmission rates
The amount of readmission's to hospital due to surgery related reasons.
Measured: 6 months
ICU/HDU admission rates
The amount of admissions to the Intensive Care Unit/High Dependency Unit due to surgery related reasons
Measured: 6 months
ICU/HDU length of stay
The amount of time (recorded in days) a patient spends in ICU/HDU due to surgery
Measured: 6 months
Clavien-Dindo Classification Sore
The most severe complication experienced by a patient will be assessed and recorded using the Clavien-Dindo Classification Score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Moran, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674815
- Sponsor's protocol ID
- CRFSJ0086
- Acronym
- PHIIT
- Status last verified
- May 2017
- First submitted
- 26 Jan 2016
- Last updated
- 18 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative High Intensity Interval Training in Patients Scheduled for Colorectal and Thoracic Surgery: The PHIIT Trial
- ClinicalTrials.gov ID
- NCT02674815
- Acronym / sponsor ID
- PHIIT / CRFSJ0086
- Conditions
- Colorectal Neoplasms, Lung Neoplasms
- Keywords
- Exercise, Preoperative, High Intensity Interval Training, Colorectal, Thoracic, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome. In colorectal surgery the rate of post-op complications is between 15-20% and the rate of 30 day mortality is 2.3%. Thoracic surgery also carries significant risk, 30 day mortality is 2.2% while the rate of post-op complications is 29.3%. Poor postoperative outcome significantly affects the patients recovery and increases hospital costs. Reducing postoperative risk therefore conveys significant benefit to the patient and the hospital.
Preoperative physical fitness is predictive of postoperative outcome in intra-abdominal and thoracic surgery. In a systematic review of 6 studies preoperative exercise interventions improved pre-op physical fitness in patients undergoing abdominal surgery, however it is unclear if this translates into an improvement in postoperative outcome.
An updated systematic review and meta-analysis was performed on the effects of pre-habilitation on postoperative outcome. While the results demonstrated that preoperative exercise interventions of 4-6 week duration reduced post-op complications a significant amount of work is still to be performed in this area.
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). Participants exercise for short periods (15 seconds) followed by 15 seconds of rest and typically continue this pattern for 30 minutes or until exhaustion.
A recent review reported HIIT programmes to be safe in individuals with coronary artery disease and stable heart failure. In agreement with this paper a recent meta-analysis noted that HIIT produced a more pronounced incremental gain in participants' mean VO2peak when compared with continuous moderate intensity exercise There are a number of factors to take into account when designing a HIIT programme e.g. duration and intensity of exercise phase and type of recovery period (active vs. passive). Two papers compared a selection of HIIT protocols for safety and time at a high percentage of VO2peak (≥ 80% VO2peak). Protocols with rest periods (passive recovery) allowed patients to exercise for longer and had lower perceived difficulties. In one study of 20 patients with CAD, HITT was prescribed with 15s exercise and passive recovery intervals at 100% Peak Power Output (PPO) or Maximal Aerobic Power (MAP) with no adverse events. PPO or MAP is the power of the last completed stage during a maximal exercise test (watts). This intervention had the highest duration above 80% VO2peak (819s) and a high completion rate of 63%. This protocol was chosen for this study.
HITT has not been investigated as a preoperative intervention to either optimize fitness prior to surgery or reduce postsurgical 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: High Intensity Interval Training Exercise programmePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for colorectal or thoracic surgery
- Able to give informed consent
- Ability to understand English
Key exclusion criteria (31 listed)
- Acute myocardial infarction
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Active endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training Exercise programmeAlso: HIITHigh 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. | Other | Intervention |
Primary outcome
Cost
Time frame: 6 months
The cost of the programme will be recorded. Expected costs include, parking, room rental charges, equipment rates, employee rates.
Adherence/Compliance
Time frame: 6 months
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.
Incidence of Adverse Events
Time frame: 6 months
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.
Satisfaction/Acceptability
Time frame: 6 months
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.
Withdrawal of participants
Time frame: 6 months
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
Protocol deviations/Adaptations
Time frame: 6 months
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)
Compliance
Time frame: 6 months
Compliance will be measured in the percentage of exercise sessions attended and successfully completed.
8 secondary outcomes
Postoperative mortality
Time frame: Up to day 30 post-op
Changes in Aerobic Capacity
Time frame: 6 months
Length of stay
Time frame: 6 months
Postoperative complications assessed using the Postoperative Morbidity Survey
Time frame: Up to 7 days post-op
Readmission rates
Time frame: 6 months
ICU/HDU admission rates
Time frame: 6 months
ICU/HDU length of stay
Time frame: 6 months
Clavien-Dindo Classification Sore
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training Exercise programme in people with Colorectal Neoplasms and Lung Neoplasms, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.