Effect of Combined Aerobic and Resisted Exercise in Breas... | NCT00877188

Studies
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors

NCT00877188

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Dec 21, 2012Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Breast Cancer
Exercise
Physical Function

Interventions

exercise

Countries

Taiwan

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

ID	Type	Description	Link
NTUH98-M1178

Status Module

Record Verification Date

Nov 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

Jan 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 22, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

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

Dec 20, 2012

Last Update Posted Date

Dec 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.

Detailed Description

Cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. Preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. However, the best exercise mode and intensity has not been well established. Little is known regarding the long term effect. No study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise	Experimental	supervised combined aerobic and resistance training for 12 weeks	Other: exercise
control	No Intervention	waist list control with usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	supervised combined aerobic and progressive resistance training for 12 weeks	exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle fitness, quality of life, upper extremity function		baseline, 12 weeks post exercise training and follow up 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stage 0 to II breast cancer diagnosed within 5 years
complete adjuvant therapy > 2 months, except hormone therapy
> 18 years

Exclusion Criteria:

disease in progress, recurrent, or metastasis
medical or musculoskeletal condition which resistance exercise is contraindicated
medication which may alter exercise response

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Jau-Yih Tsauo, PHD	Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate School of Physical Therapy, College of Medicine, NTU		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009043	Motor Activity

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

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