Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients (HITCa)

• ClinicalTrials.gov Identifier: NCT02188342
• Recruitment Status: Completed
• First Posted: July 11, 2014
• Last Update Posted: July 31, 2017
• Sponsor: University of Nottingham
• Collaborator: University Hospitals of Derby and Burton NHS Foundation Trust
• Information provided by (Responsible Party): University of Nottingham

Tracking Information

• First Submitted Date: July 10, 2014
• First Posted Date: July 11, 2014
• Last Update Posted Date: July 31, 2017
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 10, 2014)

VO2 peak [ Time Frame: After 31 days of HIT ]

Mean difference in VO2 peak following a HIT programme

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2014)

• Anaerobic threshold [ Time Frame: After 31 days of HIT ]
  Mean difference in anaerobic threshold following a HIT programme
• Muscle protein synthesis [ Time Frame: After 31 days of HIT ]
  Assessment of D2O evaluated muscle protein synthesis following HIT programme
• Body composition [ Time Frame: After 31 days of HIT ]
  DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
• Feasibility [ Time Frame: After 31 days of HIT ]
  Determination of patient compliance and adherence to HIT programme
• Quality of life [ Time Frame: After 31 days of HIT ]
  Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
• Official Title: Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
• Brief 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Preoperative Care
• Colorectal Neoplasms
• Aged
• Exercise

Intervention

Behavioral: HIT

12 HIT exercise sessions in 31 days on a stationary cycle ergometer

Study Arms

Experimental: HIT exercise training

Intervention: Behavioral: HIT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2017): 18
• Original Estimated Enrollment (submitted: July 10, 2014): 24
• Actual Study Completion Date: April 2017
• Actual Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Uncontrolled hypertension (BP > 160/100),
• Angina,
• Heart failure (class III/IV),
• Cardiac arrthymias,
• Right to left cardiac shunt,
• Recent cardiac event,
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 88 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02188342
• Other Study ID Numbers: HITCa
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Nottingham
• Study Sponsor: University of Nottingham
• Collaborators: University Hospitals of Derby and Burton NHS Foundation Trust

Investigators

• Principal Investigator: John Williams, BSc MBChB FRCA PhD; University of Nottingham

• PRS Account: University of Nottingham
• Verification Date: July 2017