NCT00877188

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

March 22, 2009

Last Update Submit

December 20, 2012

Conditions

Breast CancerExercisePhysical Function

Keywords

breast cancerexerciseupper extremity functionquality of life

Outcome Measures

Primary Outcomes (1)

  • muscle fitness, quality of life, upper extremity function

    baseline, 12 weeks post exercise training and follow up 12 weeks

Study Arms (2)

exercise

EXPERIMENTAL

supervised combined aerobic and resistance training for 12 weeks

Other: exercise

control

NO INTERVENTION

waist list control with usual care

Interventions

exerciseOTHER

supervised combined aerobic and progressive resistance training for 12 weeks

exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Physical Therapy, College of Medicine, NTU

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jau-Yih Tsauo, PHD

    Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2009

First Posted

April 7, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

December 21, 2012

Record last verified: 2012-11

Locations

TW(1)