beta
IA Trial Radar
O estudo clínico NCT06338774 (BOOST) para Inatividade física está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa

Cognitive Control to Boost Physical Activity Adherence (BOOST)

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06338774 (BOOST) é um ensaio intervencionista para Inatividade física. Seu status atual é: recrutando. O estudo começou em 1 de setembro de 2024 e pretende incluir 264 participantes. Coordenado por a Universidade de Iowa e deve ser concluído em 30 de novembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 26 de novembro de 2024.
Resumo

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
Descrição detalhada
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.

Título oficial

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

Condições
Inatividade física
Outros IDs do estudo
Número NCT
NCT06338774
Data de início (real)
2024-09-01
Última atualização postada
2024-11-26
Data de conclusão (estimada)
2027-11-30
Inscrição (estimada)
264
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
health behavior change
physical activity adherence
exercse
Propósito principal
Ciência básica
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Duplo-cego (Mascaramento duplo)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalCognitive 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.
Treinamento cognitivo
Computerized cognitive training completed on any computer or tablet with internet
EXERCÍCIO
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
ExperimentalCognitive 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.
Treinamento cognitivo
Computerized cognitive training completed on any computer or tablet with internet
EXERCÍCIO
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
Comparador ativoCasual 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.
Treinamento cognitivo
Computerized cognitive training completed on any computer or tablet with internet
EXERCÍCIO
Aerobic exercise intervention with structured exercise sessions prescribed by a study exercise specialist
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Physical Activity Adherence
Proportion of moderate to vigorous physical activity achieved while unsupervised.
6 weeks
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
40 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  • 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
University of Iowa logoUniversidade de Iowa226 estudos clínicos ativos para explorar
Responsável pelo estudo
Michelle W. Voss, Investigador principal, Associate Professor, University of Iowa
Contato central do estudo
Contato: Michelle W Voss, PhD, 319-335-2057, [email protected]
Contato: Charles Hillman, PhD, 617.373.8342, [email protected]
2 Locais do estudo em 1 países

Iowa

Psychological and Brain Sciences Building, Iowa City, Iowa, 52242, United States
Michelle W Voss, PhD, Contato, 319-335-2057, [email protected]
Ruthina Malone, Contato, 319-335-2407, [email protected]
Michelle Voss, PhD, Investigador principal
Recrutando

Massachusetts

Center for Cognitive and Brain Health, Boston, Massachusetts, 02115, United States
Charles Hillman, PhD, Contato, 617-373-8342, [email protected]
Virginia Davis, Contato, 617-373-3448, [email protected]
Charles Hillman, PhD, Investigador principal
Arthur F Kramer, PhD, Subinvestigador
Recrutando