The Effects of Exercise Training on the Health-related Fi... | NCT00813540

Studies
The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors

NCT00813540

Sponsor

AHS Cancer Control Alberta

Status

Completed

Last Update Posted

Mar 11, 2016Estimated

Enrollment

52Actual

Phase

Phase 2Phase 3

Conditions

Colonic Neoplasms

Interventions

Exercise Training
Usual Care

Countries

Canada

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

Apr 2012

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

Mar 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 22, 2008

First Posted Date

Dec 23, 2008Estimated

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

Mar 10, 2016

Last Update Posted Date

Mar 11, 2016Estimated

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

Recent studies have suggested that individuals diagnosed with colon cancer who are inactive and/or overweight, may have poorer survival outcomes. Exercise training has been shown to improve fitness and body composition in other cancer survivor groups. The investigators hypothesize that an exercise training program will be a safe, feasible, and effective intervention to improve the fitness and body composition of a group of colon cancer survivors.

Detailed Description

Not provided

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Exercise	Behavioral: Exercise Training
2	Other	Usual Care, no intervention	Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise Training	Behavioral	The exercise group will perform supervised stationary cycle ergometer exercise 3 times per week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 110% of the power output obtained at V02peak. Resistance training will be completed twice per week and will include exercises for all major muscle groups. The training will progress from 60% to 80% of 1RM over the course of the intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (Monitoring for Adverse Events)		12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Aerobic Capacity		Baseline and 12 Weeks
Change in body composition		Baseline and 12 Weeks
Feasibility (Adherence to the exercise training program)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed Stage II or III colon cancer diagnosis
Less than or equal to 1 year since the completion of all adjuvant treatment
Negative Physical Activity Readiness Questionnaire (PAR-Q) or completed Physical Activity Readiness Medical Examination (PARmed-X) form
18 years of age or older
Ability to understand and provide written informed consent in English
Willingness to be randomized
Willingness to complete outcome measures at each assessment time point
Available for the duration of study intervention period
Able to travel to our fitness centre 3/week for the study period

Exclusion Criteria:

Any absolute contraindication to to exercise testing or training
Evidence of active disease (metastatic, recurrent, or unresectable colon cancer)
Any uncontrolled medical condition or psychiatric illness that would prevent completion of the exercise program or interfere with the study assessments

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerry Courneya, Ph.D.	AHS Cancer Control Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cross Cancer Institue		Edmonton	Alberta	T6G 1Z2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided