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

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

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date July 31, 2017
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Preoperative Care
  • Colorectal Neoplasms
  • Aged
  • Exercise
Intervention  ICMJE Behavioral: HIT
12 HIT exercise sessions in 31 days on a stationary cycle ergometer
Study Arms  ICMJE Experimental: HIT exercise training
Intervention: Behavioral: HIT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2017)
18
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
24
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188342
Other Study ID Numbers  ICMJE HITCa
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE University Hospitals of Derby and Burton NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: John Williams, BSc MBChB FRCA PhD University of Nottingham
PRS Account University of Nottingham
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP