Strength Training for Older Breast Cancer Survivors

May 26, 2015 updated by: OHSU Knight Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Susan G. Komen Breast Cancer Foundation

Investigators

  • Principal Investigator: Kerri M Winters, PhD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1836
  • 050106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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