Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke

Официальное название

Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial

Обзор

This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.

Вмешательства

• Другое sham inspiratory muscle training
  This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
• Другое target inspiratory muscle training
  This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).

Первичные конечные точки

• Diaphragmatic thickness [Срок оценки: baseline, after 4 weeks of intervention]

Вторичные конечные точки (9)

• Forced Vital Capacity (FVC) [Срок оценки: baseline, after 4 weeks of intervention]
• Forced Expiratory Volume in one second (FEV1) [Срок оценки: baseline, after 4 weeks of intervention]
• Maximum Inspiratory Pressure (MIP) [Срок оценки: baseline, after 4 weeks of intervention]
• Trunk Impairment Scale (TIS) [Срок оценки: baseline, after 4 weeks of intervention]
• Sitting Balance [Срок оценки: baseline, after 4 weeks of intervention]
• Timed Up and Go Test (TUG) [Срок оценки: baseline, after 4 weeks of intervention]
• Falls efficacy scale international [Срок оценки: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention]
• 6-Minute Walk Test [Срок оценки: baseline, after 4 weeks of intervention]
• Stroke Impact Scale [Срок оценки: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention]

Критерии участия

Критерии включения

• aged between 40 and 80 years;
• breathing spontaneously;
• clinically diagnosed with ischemic and/or haemorrhagic stroke;
• stroke duration from onset between 1 and 12 months;
• no history of thoracic or abdominal surgery within the last 6 months;
• able to understand and follow verbal instructions;
• no facial palsy, or mild facial palsy without limitation of labial occlusion;
• capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
• no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
• able to independently walk at least 10 meters with or without an assistive device.

Критерии исключения

• acute myocardial infarction or acute heart failure;
• acute pain in any part of the body;
• with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
• with chronic cardiovascular dysfunction;
• Trunk Impairment Scale (TIS) score ≥ 20;
• presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06447272 · HE-OT2023/13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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