Assessing The Effectiveness of a Preoperative High Intens... | NCT02188342

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

NCT02188342

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Jul 31, 2017Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Preoperative Care
Colorectal Neoplasms
Aged
Exercise

Interventions

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Jul 10, 2014

First Submission Date that Met QC Criteria

Jul 10, 2014

First Posted Date

Jul 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 31, 2017Actual

Name	Class
University Hospitals of Derby and Burton NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIT exercise training	Experimental		Behavioral: HIT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIT	Behavioral	12 HIT exercise sessions in 31 days on a stationary cycle ergometer	HIT exercise training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VO2 peak	Mean difference in VO2 peak following a HIT programme	After 31 days of HIT

Secondary Outcomes

Measure	Description	Time Frame
Anaerobic threshold	Mean difference in anaerobic threshold following a HIT programme	After 31 days of HIT
Muscle protein synthesis	Assessment of D2O evaluated muscle protein synthesis following HIT programme

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Williams, BSc MBChB FRCA PhD	University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nottingham		Derby	Derbyshire	DE22 3DT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009043	Motor Activity

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided