Strength Training for Older Breast Cancer Survivors

Breast Neoplasm Clinical Trial

Official title:

Strength Training for Older Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591747
• Other study ID #: 1836
• Secondary ID: 050106
• Status: Completed
• Phase: N/A
• First received: December 31, 2007
• Last updated: May 26, 2015
• Start date: November 2005
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Osteoporosis, Postmenopausal

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	OHSU School of Nursing	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Dobek J, Winters-Stone KM, Bennett JA, Nail L. Musculoskeletal changes after 1 year of exercise in older breast cancer survivors. J Cancer Surviv. 2014 Jun;8(2):304-11. doi: 10.1007/s11764-013-0313-7. Epub 2013 Dec 7. — View Citation

Winters-Stone KM, Dobek J, Bennett JA, Nail LM, Leo MC, Schwartz A. The effect of resistance training on muscle strength and physical function in older, postmenopausal breast cancer survivors: a randomized controlled trial. J Cancer Surviv. 2012 Jun;6(2): — View Citation

Winters-Stone KM, Dobek J, Nail L, Bennett JA, Leo MC, Naik A, Schwartz A. Strength training stops bone loss and builds muscle in postmenopausal breast cancer survivors: a randomized, controlled trial. Breast Cancer Res Treat. 2011 Jun;127(2):447-56. doi: — View Citation

Winters-Stone KM, Leo MC, Schwartz A. Exercise effects on hip bone mineral density in older, post-menopausal breast cancer survivors are age dependent. Arch Osteoporos. 2012;7:301-6. doi: 10.1007/s11657-012-0071-6. Epub 2012 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue		12 months	No
Secondary	Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur		12 months	No