Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Aerobic Exercise and Relaxation; Aerobic Exercise Only; Relaxation Only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.; This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.; This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Survivorship; Fatigue; Relax; Cognition; Exercise