CancereHIITCaNCT02671617
Preoperative HIIT in Elderly Cancer Patients
A study testing High intensity interval training (HIIT) in people with Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This randomized control trial will determine the effect of short term high intensity interval training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to surgical resection. Half of the recruited patients will act as a control group and the other half will undergo a HIIT protocol. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- High intensity interval training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Aug 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged over 65 years (no upper age limit).
- Histologically proven, radiologically or direct visualisation leading to high clinical suspicion of cancer.
- Sufficient mobility to be able to exercise on a static exercise bike.
- Ability to give informed consent.
- Ability to travel to RDH to complete the HIIT sessions (may also rely upon dependents/relatives to provide transport).
Who cannot join
- Adjuvant systemic chemotherapy / radiotherapy treatment for this cancer. Participants with a significant past medical history of:
- Myocardial infarction (within last 6 months)
- Unstable Angina
- Heart failure (NYHA class III/IV)
- Uncontrolled Hypertension (BP>160/100)
- Previous stroke/TIA
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- Severe respiratory disease inc. known pulmonary hypertension(>25 mmHg), Forced Expiratory Volume in 1 second <1.5l.
- Brittle asthma / exercise induced asthma
- Known cerebral aneurysm.
- Inclusion in a recent (within 3 months) study which included any form of exercise, taking a drug or ionising radiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery
This randomized control trial will determine the effect of short term high intensity interval training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to surgical resection.
Half of the recruited patients will act as a control group and the other half will undergo a HIIT protocol.
Read the detailed description
High intensity interval training (HIIT) has been shown to achieve similar and in some studies better improvements in aerobic fitness versus more traditional endurance based exercise over the same time period. HIIT has also been shown to produce these improvements over a shorter timescale than other methods, in the region of 2-6 weeks. One widely reported barrier to exercise is time availability, HIIT training may be a favorable option to increase fitness as the total time spent exercising is significantly less than other methods. HIIT induces improvements in cardiovascular parameters in healthy elderly subjects, investigators aim to investigate whether these improvements can be matched in patients with cancer and further elucidate the mechanisms behind improvements seen with this type of training.
- Conditions
- Cancer
- Being tested
- High intensity interval training (HIIT)
- Keywords
- Abdominal Cavity, Aged
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training (HIIT)Other
Preoperative HIIT protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control: This group of patients will receive 'current best practice' as per UK NHS recommendations for their specific cancer management prior to surgery. |
| High intensity interval training | Experimental | Exercise: Participants in this group will attend 3-4 times per week to complete HIIT training during the period from diagnosis to surgery.
High intensity interval training (HIIT) Receives: Other: High intensity interval training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2AT (VO2 at anaerobic threshold)
Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).
Measured: Baseline and 4 weeks
Secondary outcomes (3)
VO2peak
Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).
Measured: Baseline and 4 weeks
Subjective acceptability of HIIT preoperatively (via questionnaire)
Assessment of whether our HIIT protocol is acceptable to patients in this age group.
Measured: After 4 weeks of HIIT.
Muscle protein synthesis rate changes with HIIT.
Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.
Measured: Baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Williams, MBChB FRCA PhD, Principal investigator, Nottingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671617
- Sponsor's protocol ID
- eHIITCa
- Acronym
- eHIITCa
- Status last verified
- Sep 2018
- First submitted
- 18 Jan 2016
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No individual patient data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02671617
- Acronym / sponsor ID
- eHIITCa / eHIITCa
- Conditions
- Cancer
- Keywords
- Abdominal Cavity, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 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.
This randomized control trial will determine the effect of short term high intensity interval training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to surgical resection.
Half of the recruited patients will act as a control group and the other half will undergo a HIIT protocol.
Detailed description
High intensity interval training (HIIT) has been shown to achieve similar and in some studies better improvements in aerobic fitness versus more traditional endurance based exercise over the same time period. HIIT has also been shown to produce these improvements over a shorter timescale than other methods, in the region of 2-6 weeks. One widely reported barrier to exercise is time availability, HIIT training may be a favorable option to increase fitness as the total time spent exercising is significantly less than other methods. HIIT induces improvements in cardiovascular parameters in healthy elderly subjects, investigators aim to investigate whether these improvements can be matched in patients with cancer and further elucidate the mechanisms behind improvements seen with this type of training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control: This group of patients will receive 'current best practice' as per UK NHS recommendations for their specific cancer management prior to surgery. |
| High intensity interval training | Experimental | Other: High intensity interval training (HIIT)Exercise: Participants in this group will attend 3-4 times per week to complete HIIT training during the period from diagnosis to surgery. High intensity interval training (HIIT) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged over 65 years (no upper age limit).
- Histologically proven, radiologically or direct visualisation leading to high clinical suspicion of cancer.
- Sufficient mobility to be able to exercise on a static exercise bike.
- Ability to give informed consent.
- Ability to travel to RDH to complete the HIIT sessions (may also rely upon dependents/relatives to provide transport).
Key exclusion criteria (10 listed)
- Adjuvant systemic chemotherapy / radiotherapy treatment for this cancer. Participants with a significant past medical history of:
- Myocardial infarction (within last 6 months)
- Unstable Angina
- Heart failure (NYHA class III/IV)
- Uncontrolled Hypertension (BP>160/100)
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 (HIIT)Preoperative HIIT protocol. | Other | High intensity interval training |
Primary outcome
VO2AT (VO2 at anaerobic threshold)
Time frame: Baseline and 4 weeks
Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).
3 secondary outcomes
VO2peak
Time frame: Baseline and 4 weeks
Subjective acceptability of HIIT preoperatively (via questionnaire)
Time frame: After 4 weeks of HIIT.
Muscle protein synthesis rate changes with HIIT.
Time frame: Baseline and 4 weeks.
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 14 Sep 2018.
- Individual participant dataSharing planned: No. No individual patient data will be made available.
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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.
John Williams, MBChB FRCA PhD principal investigator
Nottingham University
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 (HIIT) in people with Cancer, run by University of Nottingham at 1 site in United Kingdom.
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 5 inclusion and 10 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 14 Sep 2018. 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 United Kingdom. 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?
VO2AT (VO2 at anaerobic threshold) (time frame: Baseline and 4 weeks). 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 14 Sep 2018.