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Wearable Resistance Vest for Strengthening Respiratory Muscles (WEARVEST)

9. juli 2026 opdateret af: Dr. Husam I. Alahmadi, King Abdulaziz University

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabien, 23717
        • King Abdulaziz University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: One group, single arm study
Participants wore the vest
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Inspiratory Pressure and Maximum Expiratory Pressure
Tidsramme: 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.
Three Weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Husam I Alahmadi, PhD, King Abdulaziz University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2025

Primær færdiggørelse (Faktiske)

5. maj 2025

Studieafslutning (Faktiske)

5. maj 2025

Datoer for studieregistrering

Først indsendt

27. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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