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Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00877188
First received: March 22, 2009
Last updated: December 20, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Breast Cancer
Exercise
Physical Function
Other: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors: Upper Extremity Function, Quality of Life and Fitness Outcomes

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • muscle fitness, quality of life, upper extremity function [ Time Frame: baseline, 12 weeks post exercise training and follow up 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
supervised combined aerobic and resistance training for 12 weeks
Other: exercise
supervised combined aerobic and progressive resistance training for 12 weeks
No Intervention: control
waist list control with usual care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877188

Locations
Taiwan
Graduate School of Physical Therapy, College of Medicine, NTU
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Jau-Yih Tsauo, PHD Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00877188     History of Changes
Other Study ID Numbers: 200808034R, NTUH98-M1178
Study First Received: March 22, 2009
Last Updated: December 20, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
breast cancer
exercise
upper extremity function
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014