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Идёт набор NCT06346639

Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators

Без фазы С лечением Healthy

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: 16-day hot and cold acclimation.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 45 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
Литва
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Time Course of Adaptive Responses in Humans During a 16-day Hot and Cold Acclimation Program, and Its Effect on Health-related Indicators

Обзор

There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.

Вмешательства

  • Другое 16-day hot and cold acclimation
    Acclimation program will consist of 8 brief cold water immersions (CWI; 14°C 5 min) and 8 hot water immersions (HWI; 45°C 5 min). Heat and cold sessions will be performed on separate days (i.e., 1st day hot exposure, 2nd day cold exposure, 3rd day hot exposure, etc.).

Первичные конечные точки

  • Change in body mass and body composition (kg) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in skinfold thickness (mm) [Срок оценки: Before acclimation (1st day), 2 days and 2 weeks after the end of acclimation (44 th and 51st day)]
  • Change in body mass index (kg/m^2) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in body surface area (m^2) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in substrate oxidation [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in substrate oxidation (g/day) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in ventilation (l/min) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in breathing frequency (t/min) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in resting energy expenditure (kcal/day) [Срок оценки: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
  • Change in metabolic heat production (W) [Срок оценки: during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)]
Вторичные конечные точки (4)
  • Height (m) [Срок оценки: Before acclimation (1st day)]
  • Change in physical activity (in h) [Срок оценки: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.]
  • Change in sleep (in h) [Срок оценки: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.]
  • Change in oxygen saturation (percent) [Срок оценки: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)]

Критерии участия

Критерии включения

  • young, healthy, non-obese males and females;
  • nonsmoker;
  • no needle phobia;
  • not taking medication and/or dietary supplements that may affect experimental variables.

Критерии исключения

  • neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables;
  • involvement in temperature manipulation program for ≥ 3 months;
  • attendance at any excessive formal physical exercise or sports program.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Литва · 1 центр
  • Lithuanian Sports University — Kaunas

Идентификаторы

NCT: NCT06346639 · LithuananianSportsU-17

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗