search
Back to results

Strength Training for Older Breast Cancer Survivors

Primary Purpose

Breast Neoplasm, Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
Flexibility Training
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Progressive resistance training program 3 times a week for 12 months

Flexibility training 3 times a week for 12 months

Outcomes

Primary Outcome Measures

Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue

Secondary Outcome Measures

Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur

Full Information

First Posted
December 31, 2007
Last Updated
May 26, 2015
Sponsor
OHSU Knight Cancer Institute
Collaborators
Susan G. Komen Breast Cancer Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00591747
Brief Title
Strength Training for Older Breast Cancer Survivors
Official Title
Strength Training for Older Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Osteoporosis, Postmenopausal
Keywords
randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Progressive resistance training program 3 times a week for 12 months
Arm Title
2
Arm Type
Active Comparator
Arm Description
Flexibility training 3 times a week for 12 months
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Flexibility Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri M Winters, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU School of Nursing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21424279
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: 10.1007/s10549-011-1444-z. Epub 2011 Mar 19. Erratum In: Breast Cancer Res Treat. 2011 Jun;127(2):457.
Results Reference
result
PubMed Identifier
22193780
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):189-99. doi: 10.1007/s11764-011-0210-x. Epub 2011 Dec 23.
Results Reference
result
PubMed Identifier
24317968
Citation
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.
Results Reference
result
PubMed Identifier
23225299
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(1-2):301-6. doi: 10.1007/s11657-012-0071-6. Epub 2012 Mar 20.
Results Reference
result
PubMed Identifier
29141853
Citation
Winters-Stone KM, Wood LJ, Stoyles S, Dieckmann NF. The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153. doi: 10.1158/1055-9965.EPI-17-0766. Epub 2017 Nov 15.
Results Reference
derived

Learn more about this trial

Strength Training for Older Breast Cancer Survivors

We'll reach out to this number within 24 hrs