Postoperative ComplicationsPRE-HIITNCT03978325
Preoperative Exercise for Patients Undergoing Complex Cancer Surgery
A study testing Exercise - HIIT Intervention in people with Postoperative Complications and Physical Activity, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Physical Activity, Surgery--Complications
- What is being tested?
- Exercise - HIIT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2021to 28 Feb 2023
- 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 who are scheduled for either oesophagectomy (2-stage or 3-stage) or major lung resection for the management of primary oesophageal or lung cancer.
- Date of surgery ≥ 2 weeks from baseline assessment
- Ability to provide written informed consent
- Absence of significant co-morbidities, including metastatic disease, which may adversely impact postoperative outcome
- Successful completion of a medically supervised cardiopulmonary exercise test
- Patients with oesophageal cancer scheduled for multimodal therapy including preoperative chemo(radio)therapy and oesophagectomy will be recruited and tested prior to treatment commencement.
Who cannot join
- The American Thoracic Society/American College of Chest Physicians (ATS/ACCP) absolute contraindications for exercise testing will be applied.
- Patients undergoing video assisted lobectomy for early lung cancer will be excluded.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University of Dublin, Trinity College
Dublin
Grainne Sheill
Juliette Hussey, PhD
About this study
Official title: Preoperative Exercise to Improve Fitness in Patients Undergoing Complex Surgery for Cancer of the Lung or Oesophagus
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.
Read the detailed description
Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery, evaluation of health economics, the impact of the programme on hospital costs.
This study will take the form of a randomised controlled trial aimed primarily at improving pre-operative fitness with high intensity interval training (HIIT). HIIT prescribes aerobic exercise which alternates between periods of high intensity training and active recovery. This form of exercise training stimulates greater improvements in cardiopulmonary fitness over short periods compared to continuous aerobic training and therefore may be ideally suited to exercise prehabilitation. The primary outcome, cardiopulmonary fitness, will be measured by cardiopulmonary exercise testing and explored further using a suite of pulmonary and physical performance measures. Secondary outcomes will examine the impact of individually prescribed HIIT on postoperative outcome, postoperative physical recovery, restoration of pre-treatment fitness levels and both acute and sub-acute hospital costs. The investigators anticipate that this mode of exercise prehabilitation will attenuate postoperative risk and improve postoperative recovery, thus improving patient quality of life and having considerable economic benefits for the healthcare system.
- Being tested
- Control, Exercise - HIIT Intervention
- Keywords
- Prehabilitation, Exercise, Surgery
- Medical subject headings
- Postoperative Complications, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
The control group will receive standard pre-operative care. This involves standard pre-operative advice and a moderate intensity preoperative exercise programme.
Exercise - HIIT InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm will complete a standard prehabilitation intervention. Receives: Other: Control |
| HIIT Intervention | Experimental | This group will complete a pre-operative high intensity interval training programme. Receives: Other: Exercise - HIIT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Secondary outcomes (14)
Clavien-Dindo Scale
Measurement of the most severe complication that occurs in the postoperative period. The ordinal scale is divided into seven grades (Grade I-V, two sub-groups each for Grade III and IV), ranging from Grade I, which considers any deviation from normal, to Grade V, which describes death of the patient.
Measured: At hospital discharge (approximately 7-14 days postoperatively)
Change in the Post-Operative Morbidity Score (POMS)
The POMS is a nine-domain tool that prospectively describes and records in-hospital postoperative complications following major surgery.
Measured: On postoperative day 5, postoperative day 7 and at hospital discharge (approximately 7-14 days postoperatively)
The Comprehensive Classification Index (CCI)
This is a summary of overall morbidity including the type, number and severity of each complication experienced during the postoperative period.
Measured: At hospital discharge (approximately 7-14 days postoperatively)
Change in Pulmonary function
Pulmonary function will be measured as the first step of the CPET. This will be used to determine forced vital capacity (FVC), forced expiratory volume at 1s (FEV1) and the ratio of FEV1/FVC.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Maximum Inspiratory pressure
PImax will measured using a PowerBreathe K-series portable respiratory pressure metre. Patients will be measured at residual volume during a forceful inspiratory manoeuvre while resting in a seated position.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Muscle strength
Quadriceps muscle strength will be measured by 1 repetition maximum (1RM) in kg's using a horizontal leg extension. The 1RM is defined as the highest load that can be lifted through full range of movement at one time.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Self reported physical activity: International Physical Activity Questionnaire (IPAQ)
This questionnaire evaluates activity in metabolic equivalent (MET)-hours per week over the previous seven days. The questionnaire also quantifies average weekend and weekday sitting time. The questionnaire also quantifies average weekend and weekday sitting time.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) as well as post-operative day 30
Change in Self reported functional recovery
Participants will rate their recovery as 0%, 25%, 50%, 75% or 100% according to standardised descriptors.
Measured: At post-operative day 30
Change in Functional Performance
This will be measured using the Short Physical Performance Battery (SPPB). This measure combines the results of gait speed, chair stand and balance tests. A score lower than 10 indicates one or more mobility limitations.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Quality of Life
Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Change in Quality of Life (Specific to Lung Cancer)
For Oesophago-gastric Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the EORTC QLQ-LC 13. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Change in Quality of Life (Specific to Oesophageal Cancer)
For Oesophago-gastric Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Oesophago-gastric Cancer Subscales the EORTC QLQ-OES18 and QLQ-OES25. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Cost Effectiveness
The costs of the program will be set against the effects on HRQOL
Measured: At routine post-operative clinic visits at 6 weeks and 3 months postoperatively.
Qualitative Approach
Focus groups and interviews will be carried out with participants to gain their perspectives of the impact of the program on physical and mental well-being.
Measured: Immediately after the programme intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jul 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland, Irish Cancer Society
- Responsible party
- Principal investigator, Prof Juliette Hussey, University of Dublin, Trinity College
- Investigators
- Juliette Hussey, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978325
- Sponsor's protocol ID
- Pre-HIIT
- Acronym
- PRE-HIIT
- Status last verified
- Apr 2022
- First submitted
- 17 May 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheill G, Guinan E, O'Neill L, Normand C, Doyle SL, Moore S, Newell J, McDermott G, Ryan R, Reynolds JV, Hussey J. Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial. BMC Cancer. 2020 Apr 15;20(1):321. doi: 10.1186/s12885-020-06795-4.
PubMed 32293334
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Exercise to Improve Fitness in Patients Undergoing Complex Surgery for Cancer of the Lung or Oesophagus
- ClinicalTrials.gov ID
- NCT03978325
- Acronym / sponsor ID
- PRE-HIIT / Pre-HIIT
- Keywords
- Prehabilitation, Exercise, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland, Irish Cancer Society
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
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.
Detailed description
Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery, evaluation of health economics, the impact of the programme on hospital costs.
This study will take the form of a randomised controlled trial aimed primarily at improving pre-operative fitness with high intensity interval training (HIIT). HIIT prescribes aerobic exercise which alternates between periods of high intensity training and active recovery. This form of exercise training stimulates greater improvements in cardiopulmonary fitness over short periods compared to continuous aerobic training and therefore may be ideally suited to exercise prehabilitation. The primary outcome, cardiopulmonary fitness, will be measured by cardiopulmonary exercise testing and explored further using a suite of pulmonary and physical performance measures. Secondary outcomes will examine the impact of individually prescribed HIIT on postoperative outcome, postoperative physical recovery, restoration of pre-treatment fitness levels and both acute and sub-acute hospital costs. The investigators anticipate that this mode of exercise prehabilitation will attenuate postoperative risk and improve postoperative recovery, thus improving patient quality of life and having considerable economic benefits for the healthcare system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThis arm will complete a standard prehabilitation intervention. |
| HIIT Intervention | Experimental | Other: Exercise - HIIT InterventionThis group will complete a pre-operative high intensity interval training programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are scheduled for either oesophagectomy (2-stage or 3-stage) or major lung resection for the management of primary oesophageal or lung cancer.
- Date of surgery ≥ 2 weeks from baseline assessment
- Ability to provide written informed consent
- Absence of significant co-morbidities, including metastatic disease, which may adversely impact postoperative outcome
- Successful completion of a medically supervised cardiopulmonary exercise test
Key exclusion criteria (2 listed)
- The American Thoracic Society/American College of Chest Physicians (ATS/ACCP) absolute contraindications for exercise testing will be applied.
- Patients undergoing video assisted lobectomy for early lung cancer will be excluded.
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 |
|---|---|---|
| ControlThe control group will receive standard pre-operative care. This involves standard pre-operative advice and a moderate intensity preoperative exercise programme. | Other | Control |
| Exercise - HIIT InterventionThe 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. | Other | HIIT Intervention |
Primary outcome
Change in Cardiorespiratory Fitness
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
14 secondary outcomes
Clavien-Dindo Scale
Time frame: At hospital discharge (approximately 7-14 days postoperatively)
Change in the Post-Operative Morbidity Score (POMS)
Time frame: On postoperative day 5, postoperative day 7 and at hospital discharge (approximately 7-14 days postoperatively)
The Comprehensive Classification Index (CCI)
Time frame: At hospital discharge (approximately 7-14 days postoperatively)
Change in Pulmonary function
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Maximum Inspiratory pressure
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Muscle strength
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Self reported physical activity: International Physical Activity Questionnaire (IPAQ)
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) as well as post-operative day 30
Change in Self reported functional recovery
Time frame: At post-operative day 30
Change in Functional Performance
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Change in Quality of Life
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Change in Quality of Life (Specific to Lung Cancer)
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Change in Quality of Life (Specific to Oesophageal Cancer)
Time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
Cost Effectiveness
Time frame: At routine post-operative clinic visits at 6 weeks and 3 months postoperatively.
Qualitative Approach
Time frame: Immediately after the programme intervention (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 32293334Sheill G, Guinan E, O'Neill L, Normand C, Doyle SL, Moore S, Newell J, McDermott G, Ryan R, Reynolds JV, Hussey J. Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial. BMC Cancer. 2020 Apr 15;20(1):321. doi: 10.1186/s12885-020-06795-4.
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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.
Juliette Hussey, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise - HIIT Intervention in people with Postoperative Complications and Physical Activity, 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gráinne Sheill, PhD (01-8964809, sheillg@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness (time frame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978325, which also lists 1 linked publication.
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 13 Apr 2022.