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Набор по приглашению NCT06476288

RIC (Remote Ischemic Conditioning) in Older Individuals

Без фазы С лечением Old Age Mobility Limitation Debility

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: Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC), Low-Dose Remote ischemic conditioning (RIC).
Кому может быть актуально
Состояния в реестре: Old Age, Mobility Limitation, Debility. 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
США
Следующий шаг
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Официальное название

Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals

Обзор

The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.

Вмешательства

  • Другое Low-intensity resistance exercise training
    The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.
  • Другое High-Dose Remote ischemic conditioning (RIC)
    Treatment dose of RIC- the RIC cuff will be inflated to 20 mmHg over the participant's systolic blood pressure. The treatment dose of RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.
  • Другое Low-Dose Remote ischemic conditioning (RIC)
    This dose will be the control for the study. Low-dose RIC- the RIC cuff will be inflated to 10 mmHg below the participant's diastolic blood pressure. The low-dose RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.

Первичные конечные точки

  • Feasibility of study intervention as measured by the number of participants who completed the study [Срок оценки: Up to 6 weeks]
  • Feasibility of study intervention as measured by the attrition rate [Срок оценки: Up to 6 weeks]
  • Feasibility of study intervention as measured by the number of exercise visits attended per participant [Срок оценки: Up to 6 weeks]
  • Feasibility of study intervention as measured by the number of RIC home applications completed per participant [Срок оценки: Up to 6 weeks]
  • Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire [Срок оценки: Up to 6 weeks]
Вторичные конечные точки (7)
  • Feasibility of collecting blood samples during study as measured by the success rate of collection [Срок оценки: Up to 6 weeks]
  • Change in Short Physical Performance Battery (SPPB) [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in muscle strength as measured by dynamometry [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in exercise tolerance as measured by VO2peak testing [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in quality of life as measured by PROMIS-29 [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in Brief Resilience 5-point Likert Scale [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in vascular function as measured by arterial tonometry [Срок оценки: Baseline to post-intervention visit (approximately 7 weeks)]

Критерии участия

Критерии включения

  • Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
  • Exercises ≤ 2x/week on a regular interval

Критерии исключения

  • Unstable heart disease as determined by the investigator or study physician
  • History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing/training as determined by the investigator
  • Cognitive inability to follow directions and safely participate in exercise

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Duke University — Durham

Идентификаторы

NCT: NCT06476288 · Pro00115014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗