Preoperative CareHITCaNCT02188342
Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
A study testing HIT in people with Preoperative Care and Colorectal Neoplasms, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Preoperative Care, Colorectal Neoplasms, Aged
- What is being tested?
- HIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Apr 2017
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed colorectal cancer
- Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
- Male and female
- 18-88 years of age
Who cannot join
- Uncontrolled hypertension (BP > 160/100),
- Angina,
- Heart failure (class III/IV),
- Cardiac arrthymias,
- Right to left cardiac shunt,
- Recent cardiac event,
Show all 14Show fewer
- Previous stroke/TIA,
- Aneurysm (large vessel or intracranial),
- Severe respiratory disease including pulmonary hypertension,
- COPD/asthma with an FEV1 less than 1.5 l,
- Coagulation disorders,
- Scarring disorders.
- Current neoadjuvant chemo/radiotherapy
- Inability to complete the consent process Involvement in invasive research study in previous 3 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Derby, Derbyshire, DE22 3DT
About this study
Official title: Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.
Read the detailed description
12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes.
At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.
- Conditions
- Preoperative Care, Colorectal Neoplasms, Aged, Exercise
- Being tested
- HIT
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITBehavioural
12 HIT exercise sessions in 31 days on a stationary cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| HIT exercise training | Experimental | Not described Receives: Behavioral: HIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Mean difference in VO2 peak following a HIT programme
Measured: After 31 days of HIT
Secondary outcomes (5)
Anaerobic threshold
Mean difference in anaerobic threshold following a HIT programme
Measured: After 31 days of HIT
Muscle protein synthesis
Assessment of D2O evaluated muscle protein synthesis following HIT programme
Measured: After 31 days of HIT
Body composition
DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
Measured: After 31 days of HIT
Feasibility
Determination of patient compliance and adherence to HIT programme
Measured: After 31 days of HIT
Quality of life
Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)
Measured: After 31 days of HIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative CareStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Williams, BSc MBChB FRCA PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188342
- Sponsor's protocol ID
- HITCa
- Acronym
- HITCa
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2014
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
- ClinicalTrials.gov ID
- NCT02188342
- Acronym / sponsor ID
- HITCa / HITCa
- Conditions
- Preoperative Care, Colorectal Neoplasms, Aged, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- Jan 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Jul 2014 (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.
The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.
Detailed description
12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes.
At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIT exercise training | Experimental | Behavioral: HIT |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed colorectal cancer
- Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
- Male and female
- 18-88 years of age
Key exclusion criteria (14 listed)
- Uncontrolled hypertension (BP > 160/100),
- Angina,
- Heart failure (class III/IV),
- Cardiac arrthymias,
- Right to left cardiac shunt,
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 |
|---|---|---|
| HIT12 HIT exercise sessions in 31 days on a stationary cycle ergometer | Behavioural | HIT exercise training |
Primary outcome
VO2 peak
Time frame: After 31 days of HIT
Mean difference in VO2 peak following a HIT programme
5 secondary outcomes
Anaerobic threshold
Time frame: After 31 days of HIT
Muscle protein synthesis
Time frame: After 31 days of HIT
Body composition
Time frame: After 31 days of HIT
Feasibility
Time frame: After 31 days of HIT
Quality of life
Time frame: After 31 days of HIT
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 31 Jul 2017.
Related trials for Preoperative Care
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
Prehabilitation, Preoperative Aerobic Training
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
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, BSc MBChB FRCA PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT in people with Preoperative Care and Colorectal Neoplasms, 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 4 inclusion and 14 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 31 Jul 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 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?
VO2 peak (time frame: After 31 days of HIT). 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 31 Jul 2017.