Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Aerobic Exercise Only; Behavioral: Relaxation Only; Behavioral: Aerobic Exercise and Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT03702712

16381

Details and patient eligibility

About

The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors. Participants will complete three sessions over a seven-day period in a laboratory setting.

Full description

It is hypothesized that the combination of aerobic exercise and relaxation training could have additive effects on fatigue and related cognitive outcomes. Therefore, this study is designed to test the effects of exercise plus relaxation relative to aerobic exercise alone and relaxation training alone, over the course of three sessions within a seven day period. Participants will complete baseline and post-testing before and after the week of training, as well as pre- and post-testing at each session.

Participants will be randomized to one of three conditions:

1. Aerobic Exercise Only Condition (AERO) Participants randomized to the AERO condition will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate aerobic cycling on a stationary bike (50-70% age-predicted heart rate max). Each AERO session will end with a 20-minute quiet rest period.
2. Relaxation Only Condition (RELAX) Participants in the RELAX condition will complete three separate 20-minute sessions of relaxation training using a commercial neurofeedback device (headset & smartphone app). Each RELAX session will end with a 20-minute quiet rest period.
3. Aerobic Exercise and Relaxation Training - Intervention Condition (COMBINED) Participants randomized to the COMBINED condition will complete three separate sessions comprised of 20 minutes of AERO exercise followed by 20 minutes of RELAX training.

All participants, regardless of condition will complete brief questionnaires assessing in-the-moment fatigue and affect, before and after each randomly assigned activity session. A larger survey and battery of cognitive tests will be completed at the beginning of the first appointment and at the conclusion of the third appointment.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years and older
• previously diagnosed with breast cancer (ductal carcinoma in situ or stages I-IV)
• completed at least one cycle of chemotherapy treatment within the last 5 years
• must have reliable access to the internet
• must report at least one complaint concerning physical function, fatigue, memory, planning, thinking, negative mood, depressive symptoms, or anxiety
• must be capable of engaging in sustained stationary cycling at a moderate intensity

Exclusion criteria

• deaf in both ears
• unable to comfortably wear a pair of ear-bud headphones
• color-blind or do not have vision of at least 20/40 with the aid of contacts or glasses
• history or diagnosis of epilepsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups

Aerobic Exercise Only

Active Comparator group

Description:

Participants in the Aerobic Exercise Only arm will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate stationary aerobic cycling on a Cybex bike #525C (50-70% age-predicted heart rate max). Each session will be followed by 20 minutes of uninterrupted quiet rest. The bike will provide feedback including speed, rotations per minute, and time.

Treatment:

Behavioral: Aerobic Exercise Only

Relaxation Only

Active Comparator group

Description:

Participants in the Relaxation Only arm will complete three separate 20-minute sessions of relaxation using a commercial wearable neurofeedback (headband) device. The device's accompanying software (connected to the headband through Bluetooth) encourages breathing strategies in response to recorded brain wave activity. Real time auditory feedback includes sounds of calm (soft) or loud winds in response to detected brain activity. A visual report of affective states and the user's brain activity is given (alpha and beta waves). Participants will also be asked to take part in 20 minutes of uninterrupted quiet rest in order to match the time of the aerobic only condition.

Treatment:

Behavioral: Relaxation Only

Aerobic Exercise and Relaxation

Experimental group

Description:

Participants in the Aerobic Exercise and Relaxation arm will complete the three separate 20-minute aerobic exercise sessions (identical to the aerobic exercise only condition) followed by the same 20-minute neurofeedback-guided mindfulness training (identical to the relaxation only condition).

Treatment:

Behavioral: Aerobic Exercise and Relaxation