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

Colorectal Neoplasms Clinical Trial

— HITCa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188342
• Other study ID #: HITCa
• 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
• 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.

Related Conditions & MeSH terms

• Aged
• Colorectal Neoplasms
• Exercise
• Preoperative Care

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