Acute Cardiovascular and Neuromuscular Responses to Walking With Blood Flow Restriction (BFR) in Older Adults

Официальное название

Acute Cardiovascular and Neuromuscular Responses to Walking With Blood Flow Restriction in Older Adults: a Study Protocol for a Randomized Crossover Trial

Обзор

The goal of this clinical trial is to explore how walking combined with different levels of partial blood flow restriction (BFR) affects cardiovascular, neuromuscular, and movement (kinematic) variables in older adults. The main questions it aims to answer are: Does walking with BFR increase internal effort, as shown by cardiovascular changes, and is this effect proportional to the level of restriction? Does walking with BFR temporarily reduce neuromuscular control, and is this reduction greater at higher restriction levels? Does walking with BFR change gait movement patterns? This study uses a crossover design, meaning that each participant will complete all four conditions and serve as their own control. Participants will: Take part in walking sessions under four conditions with different levels of restriction: BFR40%, BFR80%, SHAM (0% BFR), and CON (without BFR). Have their cardiovascular responses, muscle performance, and gait movement patterns measured. Report their perceptions of the sessions, including Rate of Perceived Exertion (RPE), satisfaction, and possible side effects.

Подробное описание

This innovative research project aims to explore the effect of the novel BFR technique, combined with walking, as a non-pharmacological strategy to prevent or reverse sarcopenia and thereby improve the quality of life in sedentary older adults. BFR involves the use of a specialized pneumatic cuff to restrict venous blood flow to a muscle while partially inhibiting arterial flow, and it can be applied either at rest or in combination with exercise.

The application of BFR combined with exercise has shown promise as a tool to induce favorable physiological effects at lower training doses, that is, at lower intensities (e.g., lower intensities or slower walking or running speeds), compared to active control groups. However, despite the promising benefits reported in some studies, comprehensive investigation of the cardiovascular and neuromuscular responses during BFR combined with walking remains a largely unexplored area, both in healthy participants and special populations. This knowledge gap is particularly relevant when considering the substantial benefits that older adults and individuals with mobility limitations could gain from BFR combined with walking, especially given their potential difficulty in adhering to the minimum exercise dosage requirements recommended by the World Health Organization

Вмешательства

• Поведенческое Walking
  Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

Первичные конечные точки

• Blood pressure [Срок оценки: 25 minutes]
• Heart rate [Срок оценки: 60 minutes]
• RR-Interval Time-Domain Metrics [Срок оценки: 60 minutes]
• RR-Interval Nonlinear Metric [Срок оценки: 60 minutes]
• Maximum isometric strength [Срок оценки: 10 minutes]
• Force steadiness [Срок оценки: 10 minutes]

Вторичные конечные точки (7)

• Arterial stiffness [Срок оценки: 25 minutes]
• Temporal Gait Parameters [Срок оценки: 20 minutes]
• Temporal Gait Variability [Срок оценки: 20 minutes]
• Postural Stability [Срок оценки: 10 minutes]
• Internal subjective load [Срок оценки: 20 minutes]
• Adverse effects [Срок оценки: 20 minutes]
• Affective Responses [Срок оценки: 20 minutes]

Критерии участия

Критерии включения

• Aged between 60 and 90 years.

Критерии исключения

• Being institutionalized.
• Peripheral vascular disease, defined by an ankle-brachial index (ABI) outside the normal range (0.9-1.4).
• Uncontrolled arterial hypertension (>180/110 mmHg).
• Any contraindication to exercise, based on self-reported medical history and PAR-Q+.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Faculty of Sport of University of Porto — Porto

Испания · 1 центр

• Faculty of Education of University of La Laguna — San Cristóbal de La Laguna

Идентификаторы

NCT: NCT07275138 · CEFADE40_2024 · ED481B-2024/079

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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