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Completed

NCT Number: NCT02188342

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

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.

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Key information

Conditions

Preoperative Care Aged Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Exercise Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Derby, Derbyshire, DE22 3DT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIT

Behavioral

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

Primary outcomes

  1. VO2 peak

    Time frame: After 31 days of HIT

    Mean difference in VO2 peak following a HIT programme

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Official study title

Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness

Acronym: HITCa

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2014
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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