Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

Официальное название

Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial

Обзор

This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).

Вмешательства

• Другое sham IMT
  with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
• Другое IMT-stable group (sitting on a stable surface)
  50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
• Другое IMT-unstable group (sitting on an unstable surface)
  50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
• Другое Conventional treatment
  Participants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training.

Первичные конечные точки

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

Вторичные конечные точки (11)

• Maximum Inspiratory Pressure (MIP) [Срок оценки: baseline, after 4 weeks of intervention]
• 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]
• Sitting Balance [Срок оценки: baseline, after 4 weeks of intervention]
• Trunk Impairment Scale (TIS) [Срок оценки: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention]
• Timed Up and Go Test (TUG) [Срок оценки: baseline, after 4 weeks of intervention, 12-week follow-up after the end 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]
• Trunk muscle activity [Срок оценки: baseline, after 4 weeks of intervention]
• Anticipatory posture adjustments (APAs) time of trunk muscles [Срок оценки: baseline, after 4 weeks of intervention]

Критерии участия

Критерии включения

• Age ≥ 40 years and < 80 years;
• breathing spontaneously;
• clinically diagnosed with ischemic and/or haemorrhagic stroke;
• duration of stroke from onset falls within 1 month to 12 months after diagnosis;
• no 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;
• able to maintain a resting sitting posture without feet support for at least 30 seconds;
• no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 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 and sputum retention);
• with chronic cardiovascular dysfunction;
• Trunk Impairment Scale (TIS) score ≥ 20.
• patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the 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

Китай · 1 центр

• Shenzhen Second People's Hospital — Шэньчжэнь

Публикации

• Liu F, Jones AY, Tsang RC, Yam TT, Tsang WW. Inspiratory muscle training with balance challenge improves diaphragmatic thickness, respiratory function, balance, exercise capacity and quality of life in people after stroke: a randomised trial. J Physiother. 2026 Jan;72(1):42-52. doi: 10.1016/j.jphys.2025.12.004. Epub 2025 Dec 20. PMID 41423385

Идентификаторы

NCT: NCT06640101 · No.:HE-OT2023/13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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