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临床试验/NCT07698873
NCT07698873已完成不适用

Effects of a Novel Wearable Resistance Vest for Strengthening Respiratory Muscles: A Proof-of-Concept Study in Healthy Adult Males

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Maximum Inspiratory Pressure and Maximum Expiratory Pressure

研究概览

简要总结

Respiratory muscle weakness significantly limits functional capacity in various populations, yet conventional respiratory muscle training (RMT) often requires coached, mouthpiece-based maneuvers that may be limited by technique and adherence. This proof-of-concept study evaluated the physiological efficacy of a novel, low-cost wearable resistance vest designed to provide continuous circumferential thoracic loading during spontaneous breathing to improve respiratory muscle strength in healthy adult males.

详细描述

Respiratory muscle weakness contributes to impaired ventilation and reduced functional capacity across a wide range of respiratory, neuromuscular, and critical care conditions. Conventional respiratory muscle training (RMT) typically relies on mouthpiece-based threshold or resistive devices that require repeated volitional breathing maneuvers, appropriate technique, and sustained patient adherence. These requirements may limit their applicability in some patient populations.

This study evaluated a custom-designed wearable resistance vest developed to provide continuous circumferential thoraco-abdominal loading during spontaneous breathing. Unlike conventional RMT devices that apply resistance only during specific inspiratory or expiratory maneuvers, the wearable vest delivers a sustained external mechanical load throughout normal daily breathing. The intervention was designed to increase the work of breathing during routine activities while allowing participants to breathe naturally without performing prescribed respiratory exercises.

The study was conducted as a prospective, single-group, repeated-measures proof-of-concept investigation to determine the physiological effects of this wearable device in healthy adult males. Participants wore the individually calibrated vest during normal daily activities over a three-week intervention period with progressively increasing daily wear times. Respiratory muscle strength was assessed at baseline and weekly throughout the intervention using standardized measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).

The primary objective was to determine whether progressive circumferential thoracic loading could improve respiratory muscle strength. A secondary objective was to evaluate the physiological feasibility and tolerability of this wearable approach as a potential alternative to conventional device-based respiratory muscle training.

As a proof-of-concept study conducted in healthy volunteers, the findings are intended to establish preliminary physiological evidence and to inform the design of future controlled clinical studies evaluating this wearable technology in patient populations with respiratory muscle weakness or impaired ventilatory function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy adult males Age 18 years and older Non-smokers Free from known cardiovascular diseases Free from known respiratory diseases Free from known neuromuscular diseases Able to provide written informed consent

排除标准

  • Current smokers or history of smoking within the last 6 months Known history of chronic pulmonary disease (e.g., asthma, COPD) Known cardiovascular or neuromuscular disorders Musculoskeletal conditions preventing the comfortable use of the vest Inability to complete the three-week training protocol

研究组 & 干预措施

One group, single arm study

Experimental

Participants wore the vest

干预措施: Wearable Resistance Vest (Device)

结局指标

主要结局

Maximum Inspiratory Pressure and Maximum Expiratory Pressure

时间窗: Three Weeks

Measured at baseline and at the end of each training week using a calibrated digital pressure manometer, (MicroRPM device;Micro Medical Ltd,Kent,UK), according to ATS/ERS standards. The highest of three technically satisfactory maneuvers with \<5% variability was recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Husam I. Alahmadi

Doctor

King Abdulaziz University

研究点 (1)

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