Trial Information

Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors

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.