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

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 Fatigue Long-Term Effects Secondary to Cancer Therapy in Adults Psychosocial Effects/Treatment	Procedure: assessment of therapy complications Procedure: exercise intervention Procedure: fatigue assessment and management Procedure: laboratory biomarker analysis Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: questionnaire administration Procedure: survey administration

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control

Official Title:	Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors

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

Sponsors and Collaborators

Oregon Health and Science University Cancer Institute

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Kerri Winters-Stone, PhD	Oregon Health and Science University Cancer Institute

More Information

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

Study ID Numbers:	CDR0000593410, OHSU-CR00005268, OHSU-IRB00003316
First Received:	April 18, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00662103
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue

long-term effects secondary to cancer therapy in adults

psychosocial effects/treatment

stage I breast cancer

stage II breast cancer

stage IIIA breast cancer

stage IIIB breast cancer

stage IIIC breast cancer

breast cancer in situ

Study placed in the following topic categories:

Signs and Symptoms

Fatigue

Skin Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

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