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Cognitive Regulation Training and Exercise (CORTEX)

8 december 2014 bijgewerkt door: University of Illinois at Urbana-Champaign

Cognitive Regulation Training and Exercise (CORTEX) Trial

The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, general and exercise-specific cognitive training program plus a 4-month exercise program, to an attention-control condition involving health and wellness informational lectures plus videos. The proposed exercise program will involve both aerobic and resistive exercises. The investigators hypothesize that pre-intervention cognitive training will enhance self-regulation and self-efficacy and in turn, increase exercise adherence. The investigators also expect more positive improvements in cognitive and psychosocial function among participants in the CORTEX condition as compared to the Control condition immediately following the cognitive booster training, and across time.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Primary Aim 1: To determine the efficacy of pre-intervention cognitive training for improving exercise adherence and engagement. We hypothesize that class participation rates, physical activity counts, and self-reported exercise participation levels will be higher at 4 months for participants in the CORTEX condition relative to the Control condition. We also predict that pre-intervention training will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.

Primary Aim 2: To determine if integrated general and exercise-specific cognitive training improves facets of executive function and exercise-related efficacy judgments. We hypothesize that participants in the CORTEX condition will show faster reaction times and greater accuracy for trained and untrained-domain-relevant tasks, including dual task performance, reasoning, and thought-stopping at post-booster testing and 4-month follow-up. Furthermore, we hypothesize that CORTEX participants will show significantly higher levels of exercise efficacy judgments, and exhibit greater automaticity (faster reaction times) in making those judgments, at post-booster testing, 1 month and 4-month follow-up.

Secondary Aim 1: We will use longitudinal mediation analyses to examine mechanisms of change brought about by the cognitive training effects on exercise adherence and engagement. We hypothesize that changes in efficacy and use of self-regulatory strategies will mediate cognitive training effects on exercise adherence over 4-months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

133

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

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

45 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • men and women
  • between 45-64 years old at time of study
  • physically inactive for the past 3 months
  • have reliable access to internet
  • do NOT own or play exergames (Xbox Kinect, Playstation Move, or Nintendo Wii) regularly
  • do NOT engage in "brain-training" regularly
  • are NOT enrolled in another exercise program or cognitive training study
  • willing to be randomized
  • able to participant in the full length of the 5-month study with no more than 2 consecutive weeks of vacation

Exclusion Criteria:

  • <45 or >64 years of age at time of study
  • physically active (i.e., planned 30-min walking or exercise >2 days/wk)
  • do not have reliable access to internet
  • own and/or play exergames regularly (e.g., 1 day/wk)
  • engage in "brain-training" regularly (e.g., Sudoku or computer game-play 1 day/wk)
  • enrolled in another exercise program or cognitive training study
  • cognitive impairment as defined by TICS score <21
  • depression as defined by Geriatric Depression Scale score >5

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: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CORTEX
The CORTEX group will attend 10, 2-hour sessions for a period of four weeks prior to the initial exercise program start. One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
Gedragsmatig: CORTEX
2-hour sessions for a period of four weeks prior to the initial exercise program start. One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
exercise adherence
Tijdsspanne: 4 months (from exercise intervention baseline to 4-month post-test)
  • number of weekly classes attended (out of 16 total)
  • frequency of electronically-recorded visits to the fitness facility
4 months (from exercise intervention baseline to 4-month post-test)
exercise program engagement
Tijdsspanne: 4 month period (exercise intervention start to end)
  • self-reported physical activity
  • activity counts assessed via accelerometer
  • weekly exercise logs
  • website usage & percentage of online educational modules completed
4 month period (exercise intervention start to end)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
automaticity of exercise-related efficacy judgments
Tijdsspanne: 5-month period
-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
5-month period
exercise-related self-efficacy
Tijdsspanne: 5-month period
-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
5-month period
executive functioning
Tijdsspanne: 5-month period
-trained and untrained domains of executive functioning (e.g., dual-task ability, inhibitory control, reasoning) and memory assessed via computer-based and pencil-paper tasks; collected at baseline, 1m, and 5m
5-month period

Medewerkers en onderzoekers

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

Sponsor

University of Illinois at Urbana-Champaign

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

  • Hoofdonderzoeker: Sean P Mullen, Ph.D., University of Illinois at Urbana-Champaign

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

1 januari 2013

Primaire voltooiing (Werkelijk)

1 augustus 2014

Studie voltooiing (Werkelijk)

1 augustus 2014

Studieregistratiedata

Eerst ingediend

17 april 2013

Eerst ingediend dat voldeed aan de QC-criteria

19 april 2013

Eerst geplaatst (Schatting)

22 april 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

10 december 2014

Laatste update ingediend die voldeed aan QC-criteria

8 december 2014

Laatst geverifieerd

1 maart 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 1R21HL11341001A1

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