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Strength Training for Older Breast Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591747
First Posted: January 11, 2008
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
  Purpose
Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether physical activity and exercise interventions affect long-term symptoms, physical fitness and function, and body composition of older breast cancer survivors. Due to the combined effects of breast cancer, related treatments and aging it is likely that exercise is even more beneficial for older breast cancer survivors than for younger survivors. Along with the cancer-related symptom of fatigue common to cancer survivors, older survivors face age-related declines in bone and muscle mass, muscle strength, bone health and physical function (gait and balance) that are likely exacerbated by reduced physical activity in survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training is specifically suited to reverse or slow age-related declines in bone, muscle, strength and function and has shown promise to reduce cancer-related fatigue. However, no controlled trials of strength training in older breast cancer survivors have been conducted.

Condition Intervention
Breast Neoplasm Osteoporosis, Postmenopausal Behavioral: Resistance Exercise Behavioral: Flexibility Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Strength Training for Older Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur [ Time Frame: 12 months ]

Enrollment: 106
Study Start Date: November 2005
Study Completion Date: June 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Progressive resistance training program 3 times a week for 12 months
Behavioral: Resistance Exercise
60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
Active Comparator: 2
Flexibility training 3 times a week for 12 months
Behavioral: Flexibility Training
60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with early stage breast cancer at age of 50 or older
  • Completed adjuvant therapy, radiation +/- chemotherapy but selective estrogen receptor modulators (SERMS), (aromatase inhibitors (AIs) ok) at least 1 year prior to enrollment

Exclusion Criteria:

  • Cognitive difficulties that preclude answering the survey questions, participating in performance testing or giving informed consent
  • Diagnosed osteoporosis
  • Current regular participation in planned impact activities or resistance training (more than 2 times a week for 30 minutes at a time)
  • Medication that contraindicates participation in moderate intensity strength training or previous use of medications known to affect bone metabolism
  • Movement or neurologic disorder, not including chemo-induced peripheral neuropathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591747


Locations
United States, Oregon
OHSU School of Nursing
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Kerri M Winters, PhD Oregon Health and Science University
  More Information

Publications:
Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00591747     History of Changes
Other Study ID Numbers: 1836
050106
First Submitted: December 31, 2007
First Posted: January 11, 2008
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by OHSU Knight Cancer Institute:
randomized clinical trial
elderly
cancer survivor
bone health
body composition
signs and symptoms

Additional relevant MeSH terms:
Osteoporosis
Breast Neoplasms
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases