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

NCT ID: NCT02188342

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Preoperative Care Colorectal Neoplasms Aged Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HIT exercise training

Group Type EXPERIMENTAL

HIT

Intervention Type BEHAVIORAL

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

Interventions

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HIT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Williams, BSc MBChB FRCA PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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University of Nottingham

Derby, Derbyshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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HITCa

Identifier Type: -

Identifier Source: org_study_id

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