Меню
Идёт набор NCT07127965

Exercise Adherence and Cognitive Decline: Phase 2

Без фазы С лечением Cognitive Decline

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Goal Setting and Exercise Intensity Intervention.
Кому может быть актуально
Состояния в реестре: Cognitive Decline. Базовые параметры: 45 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Exercise Adherence and Cognitive Decline: A Goal-setting and Exercise Intensity Intervention Collaboratively Developed With the Black Community

Обзор

The purpose of this study is to conduct a test of a goals-based program to help people exercise more. This program was designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community.

Вмешательства

  • Поведенческое Goal Setting and Exercise Intensity Intervention
    Participants' goal-setting and exercise intensity are manipulated based on group assignment.

Первичные конечные точки

  • Blood Pressure [Срок оценки: Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)]
  • Activity Levels [Срок оценки: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)]
  • Sleep Levels [Срок оценки: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)]
  • Exercise Intensity [Срок оценки: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)]
  • Exercise Behavior [Срок оценки: Baseline, Visit 17 (12 months after Baseline)]
  • Exercise Behavior [Срок оценки: All study timepoints (Visits 1-17; approximately 14 months)]
  • Theoretical Mediators of Exercise Behavior [Срок оценки: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Срок оценки: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Срок оценки: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Срок оценки: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]

Критерии участия

Критерии включения

  • <3 incorrect responses on the Pfeiffer Mental Status Questionnaire
  • Ages 45 to 65
  • Consent to be randomized to conditions
  • Planning to remain in the Denver metro area for the next 14 months
  • Identify as Black or African American

Критерии исключения

  • Currently physically active (i.e., >90 min/week of moderate PA or >40 min/week of vigorous PA consistently for the past 6 months)
  • On antipsychotic medications or currently under treatment for any serious psychiatric disorder including Alzheimer's or dementia
  • Inability to walk 3 blocks without chest pain, shortness of breath, or lightheadedness
  • Inability to climb 2 flights of stairs without chest pain, shortness of breath, or lightheadedness

PCP Exclusion Criteria:

  • Answers "yes" to 1 or more of the 7 general questions of the PAR-Q+ and answers yes to any of the follow up questions.
  • Blood pressure at baseline is greater than 160/100
  • Blood pressure at baseline is between 140/90 - 160/100 and the participant is currently taking blood pressure medication
  • Blood pressure > 210/90 mmHg (for men) or > 190/90 mmHg (for women) immediately after exercise

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • Recreation Centers in the Denver Metro Area — Aurora
  • Recreation Centers in the Boulder Area — Boulder

Идентификаторы

NCT: NCT07127965 · 25-0479

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗