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Cognitive Regulation Training and Exercise (CORTEX)

8. december 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

133

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Urbana, Illinois, Forenede Stater, 61801
        • University of Illinois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
exercise adherence
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
automaticity of exercise-related efficacy judgments
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois at Urbana-Champaign

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

17. april 2013

Først indsendt, der opfyldte QC-kriterier

19. april 2013

Først opslået (Skøn)

22. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1R21HL11341001A1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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