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Набор скоро начнётся NCT06974461

Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia

Без фазы С лечением Sarcopenia Chronic Stroke Patients

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: Blood Flow Restriction (BFR) Walking, Sham Blood Flow Restriction (Sham-BFR) Walking.
Кому может быть актуально
Состояния в реестре: Sarcopenia, Chronic Stroke Patients. Базовые параметры: от 50 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial

Обзор

Effects of Blood Flow Restriction Walking on Muscle Strength and Physical Function in Chronic Stroke Patients with Sarcopenia: A Randomized, Sham-Controlled Trial Primary Objective: To evaluate the effects of BFR walking on muscle strength and physical function in chronic stroke patients with sarcopenia, compared to sham-BFR walking. Secondary Objective: (1) To explore the potential impact of BFR walking on muscle mass and vascular function in chronic stroke patients with sarcopenia. (2) To assess the influence of BFR walking on quality of life in chronic stroke patients with sarcopenia.

Вмешательства

  • Процедура Blood Flow Restriction (BFR) Walking
    Participants in this group will undergo a supervised treadmill walking program with blood flow restriction (BFR) applied using BFR pressure cuffs. The cuffs are applied to the proximal thighs, and the training pressure starts at 50% of the participant's arterial occlusion pressure (AOP), increasing every two weeks up to 200 mmHg. Walking is performed at 60% of the maximum walking speed, 20 minutes per session, 3 sessions per week for 6 weeks.
  • Процедура Sham Blood Flow Restriction (Sham-BFR) Walking
    Participants in this group will follow the same supervised treadmill walking protocol as the BFR group but with minimal cuff pressure (20 mmHg), which does not restrict blood flow. This simulates the sensation of BFR without physiological impact. The purpose is to serve as a placebo comparator. Walking is performed at 60% of maximum walking speed, 20 minutes per session, 3 sessions per week for 6 weeks.

Первичные конечные точки

  • Muscle Strength [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Motor Function - Fugl-Meyer Assessment (FMA) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Aerobic Capacity and Endurance - Six-Minute Walk Test (6MWT) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Mobility - Timed Up and Go Test (TUG) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Gait Speed - 10-Meter Walk Test (10MWT) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Five Times Sit-to-Stand Test (FTSTS) [Срок оценки: Baseline, Week 6, Week 12]
  • Handgrip Strength [Срок оценки: Baseline, Week 6, Week 12]
Вторичные конечные точки (7)
  • Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Quality of Life - Sarcopenia and Quality of Life Questionnaire (SarQoL) [Срок оценки: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • Appendicular Skeletal Muscle Mass (ASM) [Срок оценки: Baseline, Week 6, Week 12]
  • Muscle Thickness (MT) [Срок оценки: Baseline, Week 6, Week 12]
  • Pennation Angle [Срок оценки: Baseline, Week 6, Week 12]
  • Cross-Sectional Area (CSA) [Срок оценки: Baseline, Week 6, Week 12]
  • Echo Intensity (EI) [Срок оценки: Baseline, Week 6, Week 12]

Критерии участия

Критерии включения

  • Diagnosed with chronic stroke (≥6 months post-stroke)
  • Diagnosed with sarcopenia, based on AWGS 2019 criteria

Критерии исключения

  • Stroke occurred within the past 6 months
  • Resting systolic blood pressure > 200 mmHg
  • Resting diastolic blood pressure > 100 mmHg
  • Presence of implanted electronic or metallic devices that interfere with blood flow restriction cuffs
  • Contraindication to bioelectrical impedance analysis (e.g., pacemaker, ICD)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • Hong Kong Polytechnic University — Hung Hom

Идентификаторы

NCT: NCT06974461 · HSEARS20250109003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗