Clinical trial NCT03702712: Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial
Official title: Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Survivorship
Fatigue
Relax
Cognition
Exercise
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Piper Fatigue Scale
timeFrame: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
Secondary outcomes:
measure: Perceived Mental Fatigue
timeFrame: The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
measure: Energy subscale of AD ACL-SAI
timeFrame: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
measure: Tiredness subscale of AD ACL-SAI
timeFrame: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
measure: Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox
timeFrame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
measure: Working Memory- Assessed by Picture Sequence task from the NIH toolbox
timeFrame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
measure: Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox
timeFrame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
measure: Program Evaluation - Perceived Usefulness
timeFrame: This will be assessed on day 3.
measure: Program Evaluation - Perceived Ease of Use
timeFrame: This will be assessed on day 3.
measure: Program Evaluation - Enjoyment
timeFrame: This will be assessed on day 3.
measure: Program Evaluation - Satisfaction
timeFrame: This will be assessed on day 3.
measure: Program Evaluation - Open Ended
timeFrame: This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen J, Rogers WA, Petruzzello S, Trinh L, Mullen SP. Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial. Psychooncology. 2021 Feb;30(2):252-259. doi: 10.1002/pon.5561. Epub 2020 Oct 14.