Strength Training for Older Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Kerri Winters, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00591747
First received: December 31, 2007
Last updated: April 10, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Oregon Health and Science University:

Primary Outcome Measures:
  • Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 90 Years
Genders 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 SERMS, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591747

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

Publications:
Responsible Party: Kerri Winters, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00591747     History of Changes
Other Study ID Numbers: 1836, 050106
Study First Received: December 31, 2007
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
randomized clinical trial
elderly
cancer survivor
bone health
body composition
signs and symptoms

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

ClinicalTrials.gov processed this record on April 15, 2014