- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01837004
Cognitive Regulation Training and Exercise (CORTEX)
Cognitive Regulation Training and Exercise (CORTEX) Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Urbana, Illinois, 미국, 61801
- University of Illinois
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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exercise adherence
기간: 4 months (from exercise intervention baseline to 4-month post-test)
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4 months (from exercise intervention baseline to 4-month post-test)
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exercise program engagement
기간: 4 month period (exercise intervention start to end)
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4 month period (exercise intervention start to end)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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automaticity of exercise-related efficacy judgments
기간: 5-month period
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-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
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5-month period
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exercise-related self-efficacy
기간: 5-month period
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-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
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5-month period
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executive functioning
기간: 5-month period
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-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
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5-month period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sean P Mullen, Ph.D., University of Illinois at Urbana-Champaign
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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