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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preoperative Care Colorectal Neoplasms Aged Exercise Behavioral: HIT Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HIT exercise training Behavioral: HIT
12 HIT exercise sessions in 31 days on a stationary cycle ergometer


Outcome Measures
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Primary Outcome Measures :
  1. VO2 peak [ Time Frame: After 31 days of HIT ]
    Mean difference in VO2 peak following a HIT programme


Secondary Outcome Measures :
  1. Anaerobic threshold [ Time Frame: After 31 days of HIT ]
    Mean difference in anaerobic threshold following a HIT programme

  2. Muscle protein synthesis [ Time Frame: After 31 days of HIT ]
    Assessment of D2O evaluated muscle protein synthesis following HIT programme

  3. Body composition [ Time Frame: After 31 days of HIT ]
    DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme

  4. Feasibility [ Time Frame: After 31 days of HIT ]
    Determination of patient compliance and adherence to HIT programme

  5. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188342


Locations
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United Kingdom
University of Nottingham
Derby, Derbyshire, United Kingdom, DE22 3DT
Sponsors and Collaborators
University of Nottingham
University Hospitals of Derby and Burton NHS Foundation Trust
Investigators
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Principal Investigator: John Williams, BSc MBChB FRCA PhD University of Nottingham
More Information
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02188342    
Other Study ID Numbers: HITCa
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases