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OpenTrials
Completed

NCT Number: NCT07698873

Wearable Resistance Vest for Strengthening Respiratory Muscles

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Mecca Region, 23717, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Wearable Resistance Vest

Device

A custom-designed wearable resistance vest developed to provide continuous circumferential thoraco-abdominal loading during spontaneous breathing. The vest consists of a stretchable outer garment with a front zipper and internally mounted latex-free elastic resistance bands (TheraBand®, medium resistance) providing approximately 1.7 kg of circumferential resistance. Each vest was individually calibrated to approximately 95% of the participant's thoracic circumference at functional residual capacity using adjustable lateral straps and a posterior Velcro panel to standardize the applied load. Participants wore the vest during routine daily activities (excluding sleep and vigorous exercise) for progressively increasing durations of 60 minutes/day during Week 1, 90 minutes/day during Week 2, and 120 minutes/day during Week 3.

Primary outcomes

  1. Maximum Inspiratory Pressure and Maximum Expiratory Pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Acronym: WEARVEST

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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