Clinical trial NCT00662103: Aerobic Exercise, Resistance Exercise, or Flexibility and Relaxation Training in Inactive Older Female Breast Cancer Survivors
Official title: Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Fatigue
Long-term Effects Secondary to Cancer Therapy in Adults
Psychosocial Effects of Cancer and Its Treatment
Keywords: fatigue
long-term effects secondary to cancer therapy in adults
psychosocial effects of cancer and its treatment
cancer survivor
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
breast cancer in situ
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-21
Enrollment: 115
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors.

Detailed description: OBJECTIVES:

Primary:

* Compare the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes in inactive older female breast cancer survivors.
* Compare the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes.

Secondary:

* Compare the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health.
* Determine the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning.
* Compare the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence.

OUTLINE: Patients are stratified according to current use of hormone manipulation therapy (none vs tamoxifen vs arimidex). Patients are randomized to 1 of 3 intervention arms.

* Arm I (progressive, aerobic exercise program): Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months. During the first 12 months, patients attend supervised aerobic exercise sessions 2 days a week and complete 1 home-based aerobic exercise session using a modified exercise program designed by the investigative team. During the final 6 months, patients undergo aerobic exercise using an at-home program designed by the investigative team. Aerobic exercise training comprises simple stepping routines using benches of various heights while wearing a wrist monitor to record heart rate. Volume of aerobic exercise, determined by intensity (heart rate at percentage of heart rate reserve tailored to the patient) and duration (minutes in the target heart rate range), is gradually and progressively increased over the first 9 months of the exercise program. Exercise volume remains at a moderate level for the remainder of the program to provide an optimal physiologic challenge at a safe and tolerable level.
* Arm II (progressive, resistance exercise program): Patients undergo resistance exercise training 3 days a week for 18 months. During the first 12 months, patients attend supervised resistance exercise sessions 2 days a week and complete 1 home-based resistance exercise session using a modified exercise program designed by the investigative team. During the final 6 months, patients undergo resistance exercise using an at-home program designed by the investigative team. Resistance exercise training comprises the use of hand weights and barbells (for upper body resistance) and exercises in weighted vests (for lower body resistance). Patients wear a weighted vest while performing lower body strength training (chair rises, 90-degree squats, toe raises, forward lunges, lateral lunges). Patients use hand weights for upper body strength training (upright row, 1-arm row, overhead press, chest press, chest fly, biceps curl, triceps extension). Volume of strength training, determined by intensity (weight tailored to the patient) and duration (number of sets), is gradually increased from low weight and high number of repetitions to more weight and fewer repetitions over the first 6 months of the training period. Exercise volume remains at a moderate intensity for the remainder of the training period to provide an optimal physiologic challenge at a safe and tolerable level.
* Arm III (flexibility and relaxation training \[control\]): Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months. During the first 12 months, patients attend supervised flexibility and relaxation exercise sessions 2 days a week and complete 1 home-based flexibility and relaxation exercise session using a modified exercise program designed by the investigative team. During the final 6 months, patients undergo flexibility and relaxation exercises using an at-home program designed by the investigative team.

Muscle strength (measured by a one-repetition maximum test), aerobic capacity (measured by a 6-minute walk test), functional arm strength (measured by grip dynamometer), physical functioning (measured by the Physical Performance Battery), flexibility (measured by the Chair Sit and Reach Test and the Back Scratch Test), balance (measured by a one-legged stance \[Romberg\] test and a timed stance test), lymphedema (measured by the circumference of the upper arm, wrist, and a finger), body composition (measured by dual energy x-ray absorptiometry), and bone mineral density of the heel (measured by ultrasound) are assessed at baseline and periodically during the study. Patients also undergo blood and urine sample collection for cancer recurrence biomarker and bone remodeling biomarker studies.

Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Stage 0-III disease
* Completed chemotherapy or radiotherapy \> 2 years ago
* Is not a regular participant in moderate aerobic exercise (i.e., jogging, swimming) or moderate resistance exercise (\> 3 times/week for ≥ 30 minutes/session) OR in vigorous aerobic or resistance exercise (\> 3 times/week for ≥ 20 minutes/session)
* No stage IV breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Has obtained medical clearance to participate in study exercise programs
* No cognitive difficulties that would preclude answering the survey questions, participating in the performance tests, or giving informed consent
* No medical condition or movement or neurological disorder that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent medication that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
* Concurrent hormonal therapy (e.g., selective estrogen receptor modulator (SERM) or aromatase inhibitor) for breast cancer allowed

Primary outcomes:
measure: Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months
timeFrame: baseline,3 ,6 ,12, and 18 months
measure: Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months
timeFrame: baseline, 3 , 6 ,12, and 18 months
Secondary outcomes:
measure: Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months
timeFrame: baseline, 3, 6, 12, and 18 months
measure: Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months
timeFrame: baseline, 3, 6, 12, and 18 months
measure: Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ...
timeFrame: baseline, 3, 6, 12, and 18 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Knight Cancer Institute at Oregon Health and Science University
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters-Stone KM, Torgrimson-Ojerio B, Dieckmann NF, Stoyles S, Mitri Z, Luoh SW. A randomized-controlled trial comparing supervised aerobic training to resistance training followed by unsupervised exercise on physical functioning in older breast cancer survivors. J Geriatr Oncol. 2022 Mar;13(2):152-160. doi: 10.1016/j.jgo.2021.08.003. Epub 2021 Aug 21.
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.