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

Breast Cancer Clinical Trial

— RACER  

Official title:

Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702712
• Other study ID #: 16381
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Aerobic Exercise and Relaxation
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.
• Aerobic Exercise Only
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
• Relaxation Only
This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Piper Fatigue Scale	The Piper Fatigue Scale requires respondents to select their answers according to a "0" (most positive or desirable response) to "10" (most negative, fatigue is having a strong impact) scale. A total fatigue score is calculated by summing each of the 12 responses and dividing by 12. Accordingly, a total fatigue change score of 0 corresponds to no fatigue, a score of 1-3 is labeled as mild, 4-6 is labeled as moderate, and 7-10 is labeled as severe. The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages. Our operational definition of overall fatigue in this outcome is the average score across each group.	This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
Secondary	Perceived Mental Fatigue	The Perceived Mental Fatigue Questionnaire (PMFQ) is a novel inventory using 7-item Likert scale ( e.g., "My thinking requires effort," 1 = Not at all to 5 = Very true). Participants are asked to reflect on their current level of mental fatigue. The 7 items from PMFQ are summed together to create a composite fatigue value. The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages. Our operational definition of overall fatigue in this outcome is the average score across each group.	The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
Secondary	Energy subscale of AD ACL-SAI	The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so). Each of the 5 items in the Energy subscale are summed together to create an overall Energy fatigue score.The total scores from each of the three days will be used to calculate an overall energy score, which will be used to assess group level differences across averages. Our operational definition of overall energy in this outcome is the average score across each group.	This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Secondary	Tiredness subscale of AD ACL-SAI	The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so). Each of the 5 items in the Tiredness subscale are summed together to create an overall Tiredness fatigue score. This will be used to calculate a change score. The total scores from each of the three days will be used to calculate an overall tiredness score, which will be used to assess group level differences across averages. Our operational definition of overall tiredness in this outcome is the average score across each group.	This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Secondary	Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox	In the Flanker task participants focus on a given stimulus while inhibiting attention to stimuli flanking it. Participants see a row of 5 arrows and choose the button that matches the direction the middle arrow is pointing. This test yields a standardized accuracy and processing speed change score.	This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Secondary	Working Memory- Assessed by Picture Sequence task from the NIH toolbox	The Picture Sequence tasks asks participants to remember a specific order of events as demonstrated by the task itself on a screen. At the conclusion of the demonstration, the events are scrambled and the participants are instructed to place them back in the correct order. This task yields a standardized accuracy change score.	This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Secondary	Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox	In the Dimensional Change Card Sort Task, participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The ensuing "switch" trials are also employed, in which the participant is required to change the dimension being matched. For example, after 4 straight trials matching on shape, the participant may be asked to match on color on the next trial and then go back to shape, thus requiring the cognitive flexibility to quickly choose the correct stimulus. The NIH toolbox automatically calculates an overall raw score, which takes into account both accuracy and reaction time, used to create a change score.	This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Secondary	Program Evaluation - Perceived Usefulness	All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived usefulness questionnaire (e.g., "Using the technology-delivered relaxation training program improved my thinking"). These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program. The 5 item's responses will be averaged and then used for a total perceived usefulness score.	This will be assessed on day 3.
Secondary	Program Evaluation - Perceived Ease of Use	All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived ease of use questionnaire (e.g., "I found the technology-delivered relaxation training program to be easy to use"). These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program. The 5 item's responses will be averaged and then used for a total perceived usefulness score.	This will be assessed on day 3.
Secondary	Program Evaluation - Enjoyment	An evaluation of participants' enjoyment of the trial will also be included. Five questions (e.g., I enjoyed using the mindfulness training device) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered. The 5 item's responses will be averaged and then used for a total perceived usefulness score.	This will be assessed on day 3.
Secondary	Program Evaluation - Satisfaction	An evaluation of participants' satisfaction with components of the trial will also be included. Five questions (e.g., I am satisfied with the outcomes experienced following mindfulness training) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered. The 5 item's responses will be averaged and then used for a total perceived usefulness score.	This will be assessed on day 3.
Secondary	Program Evaluation - Open Ended	An open ended evaluation of participants' experience with the trial will also be included. This qualitative question will ask participants to expand upon their overall likes and dislikes, recommendations, and modifications will be included. Open ended responses will be used to design and apply future interventions in this area.	This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.

External Links

•   Exercise, Technology, and Cognition Laboratory