Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance
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: Hyperbaric Oxygen Therapy - HBOT, Intermittent Hypoxic Training - IHT.
- Кому может быть актуально
- Состояния в реестре: Healthy Active Athletes. Базовые параметры: 18 лет — 45 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Израиль
- 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
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study
Обзор
Comparing the effect of HBOT and IHT on aerobic performance of athletes.
Подробное описание
Enhanced physical performance is the goal of all professional and non-professional athletes. There are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: IHT and HBOT.
This study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - Maximal exercise test for evaluating VO2MAX and ventilatory thresholds, time to exhaustion, 30 seconds Wingate test, agility test, muscle biopsy, blood tests, brain MRI, cognitive tests and exercise cognitive test.
After signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. The IHT group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total.
The HBOT group will receive 40 daily hyperbaric sessions, five days per week. Each session will include 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Three times per week, as the IHT group, the HBOT group will have a guided training session, according an individualized training protocol.
Both groups, IHT and HBOT, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. The IHT group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at O2 concentration of 15.2% that stimulates a 2500-2600m height. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment
Physical performance evaluations will be conducted on 3 different times post interventions - a day last intervention, 3 weeks after and 2 months after - in order to analyze the long term effect of each intervention.
Вмешательства
- Устройство Hyperbaric Oxygen Therapy - HBOT
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes - Устройство Intermittent Hypoxic Training - IHT
Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.
Первичные конечные точки
- Cardiopulmonary exercise test (CPET) [Срок оценки: Baseline, 11 weeks]
Вторичные конечные точки (8)
- Cardiopulmonary exercise test (CPET) [Срок оценки: 8 weeks, 16 weeks]
- Time To Exhaustion [Срок оценки: Baseline, 11 weeks, 16 weeks]
- Wingate 30 seconds anaerobic test [Срок оценки: Baseline, 11 weeks, 16 weeks]
- Muscle biopsy for mitochondrial function [Срок оценки: Baseline, 11 weeks]
- Blood test for evaluation of CBC [Срок оценки: Baseline, 11 weeks, 16 weeks]
- Blood test for evaluation of HIF-1α [Срок оценки: Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks]
- Blood test for evaluation of Telomeres length [Срок оценки: Baseline,11 weeks, 16 weeks]
- Blood test for evaluation of mitochondrial function [Срок оценки: Baseline,11 weeks]
Критерии участия
Критерии включения
- Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg
- Age 18-45
- Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.
- Subject willing and able to read, understand and sign an informed consent
Критерии исключения
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Active malignancy
- Active smokers
- Previous treatment of HBOT for any reason prior to study enrollment.
- Chest pathology incompatible with pressure changes
- Major orthopedic injury at the past 3 months
- Inner ear disease
- Lung pathology
- The inability to perform an awake brain MRI
- Claustrophobia
- Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.)
- Comorbidities and medications that rule out the subject
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Израиль · 1 центр
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Идентификаторы
NCT: NCT05447416 · 0032-20-ASF