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Идёт набор NCT07025070

The Link Between Physical Activity and Brain Health in Healthy Adults

— Наблюдательное Alzheimer Disease Inactivity Preventive Therapy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Alzheimer Disease, Inactivity, Preventive Therapy. Базовые параметры: 40 лет — 75 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
Испания
Следующий шаг
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Официальное название

The Link Between Strength and Endurance Training and Brain Health in Healthy Adults: A Comparative Study of Former Professional Athletes and Sedentary Individuals

Обзор

The goal of this observational study is to investigate the cross-sectional relationship between physical activity and brain health from a multiscale approach (neuropsychology, neuroimaging, peripheral biomarkers and genetics) in former athletes and sedentary individuals. The main question it aims to answer is: Do former athletes have better brain structure than sedentary people? Evaluating the differences in neurodegenerative processes between competitive training and sedentary and inactivity.

Первичные конечные точки

  • Concentration of brain-derived neurotrophic factor (BDNF) in plasma (pg/mL) [Срок оценки: Baseline]
  • Concentration of total tau protein in plasma (pg/mL) [Срок оценки: Baseline]
  • Hippocampal volume measured by high-resolution 3 T T1-weighted MRI (mm³) [Срок оценки: Baseline]
  • Resting-state functional connectivity between primary motor cortex and supplementary motor area measured by 3 T fMRI (Fisher-Z) [Срок оценки: Baseline]
  • Digit Span Forward maximum span length (digits) [Срок оценки: Baseline]
  • Trail Making Test Part A completion time (seconds) [Срок оценки: Baseline]
  • Digit Span Backward maximum span length (digits) [Срок оценки: Baseline]
  • Trail Making Test Part B completion time (seconds) [Срок оценки: Baseline]
  • Verbal fluency (F-A-S) total words in 60 s (count) [Срок оценки: Baseline]
  • Stroop Color-Word interference score (seconds) [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Maximal oxygen uptake (VO₂max) measured by CPET with ramp protocol on treadmill (mL·kg-¹·min-¹) [Срок оценки: Baseline]
  • Mean daily minutes of moderate-to-vigorous physical activity measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day) [Срок оценки: Baseline]
  • Body mass index (BMI) calculated from weight and stadiometer-measured height (kg/m²) [Срок оценки: Baseline]
  • Peak force of mid-thigh-pull test measured by portable force dynamometer (N) [Срок оценки: Baseline]
  • Handgrip strength measured by grip dynamometer (kg) [Срок оценки: Baseline]
  • Timed Up-and-Go (TUG) test completion time (seconds) [Срок оценки: Baseline]
  • Balance stability and speed score measured by TANITA force platform (unitless) [Срок оценки: Baseline]
  • Percentage body fat measured by multifrequency bioimpedance analyzer InBody system (%) [Срок оценки: Baseline]
  • Skeletal muscle mass measured by multifrequency bioimpedance analyzer InBody system (kg) [Срок оценки: Baseline]
  • Waist circumference measured by flexible tape at midpoint between lowest rib and iliac crest (cm) [Срок оценки: Baseline]
  • Hip circumference measured by flexible tape at level of greater trochanters (cm) [Срок оценки: Baseline]
  • Serum triglycerides measured by enzymatic colorimetric assay (mg/dL) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Group A: ex-athletes and continue to perform regular physical exercise (minimum 3 days/week of moderate-vigorous intensity).
  • Group B: sedentary individuals, (i.e., perform <150 min of moderate intensity exercise per week or IPAQ score<600 MET min/week).
  • In both groups (A and B) the conditions of physical exercise or sedentary lifestyle must have been maintained for at least 6 months prior to the evaluations.
  • Not having a history of neurological or psychiatric disorder or suffering from a serious medical condition

Критерии исключения

  • Medical conditions that have a high risk of associated cognitive symptoms.
  • Severe head injury with loss of consciousness within the previous 5 years.
  • Alcoholism (>3 alcoholic drinks per day).
  • Chronic use of anxiolytics, neuroleptics, narcotics, anticonvulsants, or sedative hypnotics.
  • Hearing or visual impairment that would preclude testing
  • History of neurological disease with clinically relevant impact on cognition (e.g. cerebrovascular disease).
  • Incidental structural brain findings with impact on cognitive impairment or survival (e.g., malignant brain tumor).
  • Presence of severe systemic disease (e.g., cancer under treatment).
  • Consumption of anabolic substances.
  • Problems understanding spoken or written Spanish.
  • Those with pacemakers or metallic implants that may interfere with the MRI.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Faculty of Physical Activity and Sports Sciences (INEF) — Madrid

Идентификаторы

NCT: NCT07025070 · MINAEPSLRE-MMGG-DATOS-20240219 · S2022/BMD-7236

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗