Strength Training for Older Breast Cancer Survivors

NCT00591747 | Completed DMC

• 2 other identifiers: 1836050106
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Osteoporosis, Postmenopausal

Keywords

randomized clinical trial; elderly; cancer survivor; bone health; body composition; signs and symptoms

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

1

EXPERIMENTAL

Progressive resistance training program 3 times a week for 12 months

Behavioral: Resistance Exercise

2

ACTIVE COMPARATOR

Flexibility training 3 times a week for 12 months

Behavioral: Flexibility Training

Interventions

Resistance Exercise BEHAVIORAL

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

1

Flexibility Training BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

OHSU School of Nursing

Portland, Oregon, 97239, United States

Location

Related Publications (6)

• 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.

  PMID: 21424279 RESULT

• 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.

  PMID: 22193780 RESULT

• 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.

  PMID: 24317968 RESULT

• 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.

  PMID: 23225299 RESULT

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

• 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.

  PMID: 29141853 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis, Postmenopausal; Signs and Symptoms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerri M Winters, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: November 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2011
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)