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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02188342
Other study ID # HITCa
Secondary ID
Status Completed
Phase N/A
First received July 10, 2014
Last updated July 26, 2017
Start date January 2015
Est. completion date April 2017

Study information

Verified date July 2017
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 88 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom University of Nottingham Derby Derbyshire

Sponsors (2)

Lead Sponsor Collaborator
University of Nottingham Derby Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2 peak Mean difference in VO2 peak following a HIT programme After 31 days of HIT
Secondary Anaerobic threshold Mean difference in anaerobic threshold following a HIT programme After 31 days of HIT
Secondary Muscle protein synthesis Assessment of D2O evaluated muscle protein synthesis following HIT programme After 31 days of HIT
Secondary Body composition DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme After 31 days of HIT
Secondary Feasibility Determination of patient compliance and adherence to HIT programme After 31 days of HIT
Secondary Quality of life Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS) After 31 days of HIT
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