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Набор скоро начнётся NCT07573995

Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults

Без фазы С лечением Frailty Syndrome Older Adults Blood Flow Restriction (BFR) Training Effects Inspiratory Muscle Training

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: Exercise, Sham Control.
Кому может быть актуально
Состояния в реестре: Frailty Syndrome, Older Adults, Blood Flow Restriction (BFR) Training Effects, Inspiratory Muscle Training. Базовые параметры: от 65 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
Тайвань
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

Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial

Обзор

This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.

Подробное описание

This is a parallel randomized controlled trial. 30 participants who are older adults with frailty will be enrolled.

Eligible participants who complete the baseline measurements will be randomly allocated to a combined BFR and IMT intervention group (N=15) or in the control group with BFR and sham IMT (N=15).

Primary outcomes include feasibility and physical function (i.e., the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), and Time Up and Go (TUG) test). Secondary outcomes include respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events. All outcomes will be assessed at baseline (T0) and immediately after the 6-week intervention period (T1) in both groups.

Вмешательства

  • Поведенческое Exercise
    Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity. For the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to
  • Поведенческое Sham Control
    Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function

Первичные конечные точки

  • Recruitment rate [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Attrition rate [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Exercise Enjoyment [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Short Physical Performance Battery (SPPB) [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • 6-Minute Walk Test (6MWT) [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Time Up to Go (TUG) [Срок оценки: T0 = baseline; T1 = immediately after intervention]
Вторичные конечные точки (8)
  • Respiratory Muscle Strength [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Handgrip Strength [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Five-times sit-to-stand [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Frailty level [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Fall Efficacy [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Adverse events [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Fat mass [Срок оценки: T0 = baseline; T1 = immediately after intervention]
  • Fat-free mass [Срок оценки: T0 = baseline; T1 = immediately after intervention]

Критерии участия

Критерии включения

  • Community-dwelling adults aged 65 years and older who are classified as at least "vulnerable" using the Clinical Frailty Scale (score ≥4).
  • Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE).

Критерии исключения

  • (1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders)
  • (2) have high-risk factors for exercise, such as uncontrolled hypertension (>150 mmHg systolic blood pressure (SBP) / >90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis
  • (3) have hematological disorders or are using hematology related-medications
  • (4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases
  • (5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and
  • (6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.

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

Тайвань · 1 центр
  • Taipei Medical University — Taipei

Идентификаторы

NCT: NCT07573995 · 2025-UAAT-UTS02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗