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임상시험 NCT06338774 (BOOST)은(는) 신체 비활동에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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카드 뷰

Cognitive Control to Boost Physical Activity Adherence (BOOST)

모집중
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06338774 (BOOST)은(는) 신체 비활동에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2024년 9월 1일에 시작되어 264명의 참여자를 모집하고 있습니다. 아이오와 대학교이(가) 진행하며, 2027년 11월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 11월 26일에 갱신되었습니다.
간단한 개요

This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:

  • Can cognitive training designed to improve cognitive control improve physical activity adherence?
  • What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?

Participants will

  • Complete a 6-week home-based, computerized cognitive training program
  • Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer
  • Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer
  • Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness
상세한 설명
Participants will first be screened to ensure eligibility for participating in moderate to vigorous intensity exercise based on health history and approval from their primary physician or equivalent.

Participants will then complete pre-testing and a three-phased intervention. Pre-intervention sessions include study screening, cognitive testing, physical activity assessment, and sub-maximal cardiorespiratory fitness testing.

Participants will then be randomized into one of three cognitive training programs for a 6-week cognitive training intervention. The cognitive training program includes 15 hours of progressive adaptive training. Participants complete 30 min of training 5 days a week to complete a dose of 15 hours of cognitive training. A minimum of 10 hours of completed cognitive training is needed to progress to the exercise training program.

Upon completion of cognitive training, participants will complete testing to assess changes in cognitive function, and then be enrolled in a two-phase exercise intervention. The 12-week exercise program includes a first 6-week introductory and fully supervised training program that builds towards meeting the minimum suggested exercise per week for long-term health benefits (150 minutes/week of moderate intensity exercise). Following the first 6 weeks, participants will be prescribed a maintenance program to be completed fully at home with their heart rate monitor from the study team, and with safety monitoring from our exercise specialist.

After completing the second 6-week exercise intervention, participants will again complete the cognitive and cardiorespiratory fitness testing they did during pre-intervention sessions.

공식 제목

Targeting Cognitive Control to Improve Physical Activity Adherence in Midlife for Alzheimer's Risk Reduction

질환/상태
신체 비활동
기타 연구 식별자
NCT 번호
실제 연구 시작일
2024-09-01
최신 업데이트 게시
2024-11-26
예상 연구 완료일
2027-11-30
계획된 등록 인원
264
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
health behavior change
physical activity adherence
exercse
주요 목적
기초과학
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Cognitive Control: Neutral (CC-N)
Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented are neutral (not emotionally valenced). After each session, the difficulty of the next session is updated.
인지 훈련
Computerized cognitive training completed on any computer or tablet with internet
운동
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
실험적Cognitive Control: Emotionally Valenced (CC-E)
Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented within the tasks are emotionally valenced.
인지 훈련
Computerized cognitive training completed on any computer or tablet with internet
운동
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
활성 대조군Casual Games
Composed of 6 commercially available computer games. It matches the experimental treatment program in overall program use intensity, time-spent attending, delivered rewards, and overall engagement.
인지 훈련
Computerized cognitive training completed on any computer or tablet with internet
운동
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
주요결과변수
결과변수측정값 설명시간 범위
Physical Activity Adherence
Proportion of moderate to vigorous physical activity achieved while unsupervised.
6 weeks
적격성 기준

연령대
성인, 노인
최소 연령
40 Years
참여 가능한 성별
전체
건강한 참가자 허용
  • Between the ages of 40 and 65 years old
  • Full-time working status of an average of 35 hrs./week or more
  • Scoring as "Low Active" by the short form of the International Physical Activity Questionnaire (IPAQ)
  • Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire
  • Approval from their Primary Care Physician for approval to participate in the prescribed training program
  • Corrected vision of 20/40
  • Fluent in English to ensure instructions for cognitive assessments and training are understood clearly

  • Impairments in hearing inhibiting the ability to discuss study instructions or directions
  • Visual impairments that prevent the perception of color, or loss of sight in the visual field
  • Qualify as "high risk" for exercise-induced adverse events by American College of Sports Medicine criteria will be excluded, which includes known or symptomatic chronic cardiovascular or metabolic disease
  • Not fluent in English
  • Inability to comply with experimental instructions or access a tablet or computer to complete computerized training
  • Previous diagnosis of a neurological or psychiatric condition, including diagnosis with any of the following: major depression, Attention Deficit Disorder or attention-deficit/hyperactivity disorder (ADHD), schizophrenia or bipolar disorder, multiple sclerosis, epilepsy, meningitis, Parkinson's disease, stroke, Transient Ischemic Attack (TIA), or brain aneurysm surgery.
  • Previous diagnosis of a heart condition, cardiovascular disease, or a recent cardiovascular event (such as high blood pressure or cholesterol) that would increase the risk for an adverse event in response to vigorous exercise, Chronic obstructive pulmonary disease (COPD), uncontrolled asthma (this includes anyone who has asthma but is not on medication.
  • Previous diagnosis of a chronic condition such as cystic fibrosis, unregulated thyroid disorder (this includes anyone with thyroid disease that is not on medication), untreated diabetes, renal or liver disease, heart murmur, arrhythmia, or irregular heartbeat.
  • Previous brain surgery or injury associated with concussion or loss of consciousness that required rehabilitation or caregiver assistance to regain function (i.e., dressing/personal hygiene)
  • Previous diagnosis of Alzheimer's or related dementias
  • Current or previous cancer treatments within the last 6 months
  • Pregnant or trying to get pregnant
연구 책임자
Michelle W. Voss, 책임연구자, Associate Professor, University of Iowa
연구 대표 연락처
연락처: Michelle W Voss, PhD, 319-335-2057, [email protected]
연락처: Charles Hillman, PhD, 617.373.8342, [email protected]
2 1개국에 임상시험 장소

Iowa

Psychological and Brain Sciences Building, Iowa City, Iowa, 52242, United States
Michelle W Voss, PhD, 연락처, 319-335-2057, [email protected]
Ruthina Malone, 연락처, 319-335-2407, [email protected]
Michelle Voss, PhD, 책임연구자
모집중

Massachusetts

Center for Cognitive and Brain Health, Boston, Massachusetts, 02115, United States
Charles Hillman, PhD, 연락처, 617-373-8342, [email protected]
Virginia Davis, 연락처, 617-373-3448, [email protected]
Charles Hillman, PhD, 책임연구자
Arthur F Kramer, PhD, 공동연구자
모집중