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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Aerobic Exercise Only

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.

Group Type ACTIVE_COMPARATOR

Aerobic Exercise Only

Intervention Type BEHAVIORAL

This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.

Relaxation Only

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.

Group Type ACTIVE_COMPARATOR

Relaxation Only

Intervention Type BEHAVIORAL

This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.

Aerobic Exercise and Relaxation

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).

Group Type EXPERIMENTAL

Aerobic Exercise and Relaxation

Intervention Type BEHAVIORAL

This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.

Interventions

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Aerobic Exercise and Relaxation

This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.

Intervention Type BEHAVIORAL

Aerobic Exercise Only

This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.

Intervention Type BEHAVIORAL

Relaxation Only

This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes