Effects of Training With a Pressure Cuff on Cellular Energy Activity

Официальное название

Influence of Short-Term Conventional Cuff-Assisted Training on Mitochondrial Capacity: A Non-Invasive Investigation

Обзор

This study investigates low-load, cuff-assisted training to improve mitochondrial capacity. The intervention is carried out using automated pressure cuffs, applying an individualized pressure of 70% of the limb occlusion pressure. This approach reflects the current scientific consensus for safe and effective use in clinical populations. Within a rehabilitation setting, two training modalities are compared: intermittent strength training and alternating continuous endurance training. Muscle oxygen saturation is measured non-invasively using near-infrared spectroscopy.

Вмешательства

• Диагностический тест Application of pressure cuffs during strength training
  Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups.
• Диагностический тест Application of pressure cuffs during endurance training
  Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups
• Диагностический тест Conventional clinical rehabilitation program without the use of pressure cuffs
  Pre/Post comparison of mitochondrial capacity of the m. vastus lateralis muscle and muscle morphology between the groups

Первичные конечные точки

• Determination of changes in the mitochondrial capacity of skeletal muscle (of the thigh muscle, vastus lateralis; measured non-invasively) [Срок оценки: From enrollment to the end of treatment at 6 weeks.]

Вторичные конечные точки (3)

• Minimum and maximum oxygen saturation (SmO₂) during application of pressure cuffs (measured via NIRS) [Срок оценки: From enrollment to the end of treatment at 6 weeks.]
• Changes in total hemoglobin (tHb) as a measure of local blood volume (measured via NIRS) [Срок оценки: From enrollment to the end of treatment at 6 weeks.]
• Assessment of subjective functional mobility using the "Lower Extremity Functional Scale" (LEFS) questionnaire [Срок оценки: From enrollment to the end of treatment at 6 weeks.]

Критерии участия

Inclusion:

• Medically confirmed generalized deconditioning with reduced muscle strength
• Medical certification of suitability for functional lower-extremity strength training
• Written informed consent after an adequate reflection period

Exclusion:

• Unstable arrhythmias, myocardial ischemia, symptomatic blood pressure drops or hypertension (>160/100 mmHg despite medication)
• History of thrombosis or acute swelling/skin discoloration of the legs
• Dizziness, confusion, cyanosis, or unexplained fatigue
• Participant's wish to withdraw or not participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07494721 · 2026/STGAG_HB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗