Aerobic Exercise, Resistance Exercise, or Flexibility and Relaxation Training in Inactive Older Female Breast Cancer Survivors - Full Text View

Sponsor:	Oregon Health and Science University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00662103

Purpose

RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors.

Condition	Intervention
Breast Cancer Cancer Survivor Fatigue Long-term Effects Secondary to Cancer Therapy in Adults Psychosocial Effects of Cancer and Its Treatment	Behavioral: exercise intervention Other: laboratory biomarker analysis Other: questionnaire administration Other: survey administration Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ]
Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ]
Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ]
Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ... [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	March 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- Stage 0-III disease
Completed chemotherapy or radiotherapy > 2 years ago
Is not a regular participant in moderate aerobic exercise (i.e., jogging, swimming) or moderate resistance exercise (> 3 times/week for ≥ 30 minutes/session) OR in vigorous aerobic or resistance exercise (> 3 times/week for ≥ 20 minutes/session)
No stage IV breast cancer
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Has obtained medical clearance to participate in study exercise programs
No cognitive difficulties that would preclude answering the survey questions, participating in the performance tests, or giving informed consent
No medical condition or movement or neurological disorder that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent medication that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
Concurrent hormonal therapy (e.g., selective estrogen receptor modulator [SERM] or aromatase inhibitor) for breast cancer allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662103

Locations

United States, Oregon
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu

Sponsors and Collaborators

Oregon Health and Science University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kerri Winters-Stone, PhD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000593410, OHSU-CR00005268, OHSU-IRB00003316
Study First Received:	April 18, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00662103 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
long-term effects secondary to cancer therapy in adults
psychosocial effects of cancer and its treatment
cancer survivor
stage I breast cancer

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
breast cancer in situ

Additional relevant MeSH terms:

Signs and Symptoms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Fatigue
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009