- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877188
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors
December 20, 2012 updated by: National Taiwan University Hospital
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors: Upper Extremity Function, Quality of Life and Fitness Outcomes
The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- Graduate School of Physical Therapy, College of Medicine, NTU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise
supervised combined aerobic and resistance training for 12 weeks
|
supervised combined aerobic and progressive resistance training for 12 weeks
|
|
No Intervention: control
waist list control with usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
muscle fitness, quality of life, upper extremity function
Time Frame: baseline, 12 weeks post exercise training and follow up 12 weeks
|
baseline, 12 weeks post exercise training and follow up 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jau-Yih Tsauo, PHD, Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 22, 2009
First Submitted That Met QC Criteria
April 6, 2009
First Posted (Estimate)
April 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200808034R
- NTUH98-M1178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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