- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07698873
Wearable Resistance Vest for Strengthening Respiratory Muscles (WEARVEST)
Effects of a Novel Wearable Resistance Vest for Strengthening Respiratory Muscles: A Proof-of-Concept Study in Healthy Adult Males
Studieoversigt
Status
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Mecca Region
-
Jeddah, Mecca Region, Saudi Arabien, 23717
- King Abdulaziz University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
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
Sponsor
Efterforskere
- Ledende efterforsker: Husam I Alahmadi, PhD, King Abdulaziz University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HA-02J-008
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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