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

15 april 2019 bijgewerkt door: Sean Mullen, University of Illinois at Urbana-Champaign

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Urbana, Illinois, Verenigde Staten, 61801
        • University of Illinois at Urbana-Champaign

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 120 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Aerobic Exercise Only
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
Actieve vergelijker: 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.
Gedragsmatig: Relaxation Only
This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
Experimenteel: 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).
Gedragsmatig: Aerobic Exercise and Relaxation
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Piper Fatigue Scale
Tijdsspanne: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perceived Mental Fatigue
Tijdsspanne: The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
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).
Energy subscale of AD ACL-SAI
Tijdsspanne: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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).
Tiredness subscale of AD ACL-SAI
Tijdsspanne: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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).
Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox
Tijdsspanne: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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)
Working Memory- Assessed by Picture Sequence task from the NIH toolbox
Tijdsspanne: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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)
Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox
Tijdsspanne: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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)
Program Evaluation - Perceived Usefulness
Tijdsspanne: This will be assessed on day 3.
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.
Program Evaluation - Perceived Ease of Use
Tijdsspanne: This will be assessed on day 3.
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.
Program Evaluation - Enjoyment
Tijdsspanne: This will be assessed on day 3.
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.
Program Evaluation - Satisfaction
Tijdsspanne: This will be assessed on day 3.
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.
Program Evaluation - Open Ended
Tijdsspanne: This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Illinois at Urbana-Champaign

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 oktober 2018

Primaire voltooiing (Werkelijk)

28 februari 2019

Studie voltooiing (Werkelijk)

28 februari 2019

Studieregistratiedata

Eerst ingediend

3 oktober 2018

Eerst ingediend dat voldeed aan de QC-criteria

8 oktober 2018

Eerst geplaatst (Werkelijk)

11 oktober 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 april 2019

Laatste update ingediend die voldeed aan QC-criteria

15 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16381

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified participant data will be made available for all primary and secondary outcome measures. Included documentation will be comprised of study protocol, statistical analyses protocols, informed consent documentation, and layperson research procedures. Additionally information will be made available upon request. Data access requests will be reviewed by the primary investigators. Requestors will be required to sign a Data Access Agreement.

IPD-tijdsbestek voor delen

Although this is not an NIH funded study, we will update these records within 1 year of data collection completion per NIH guidelines.

IPD-toegangscriteria voor delen

Data will be accessible on an open site (e.g., Open Science Framework https://osf/io/) with a request to interested parties to engage with the investigative team about any publication of these data in an effort to avoid redundancy. Appropriate authorship crediting investigators involved in the parent study conceptualization, and any consultation regarding data interpretation should be sought by any researchers interested in publishing these data.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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