Wearable Resistance Vest for Strengthening Respiratory Muscles

NCT07698873 | Completed DMC

• 1 other identifier: HA-02J-008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Male

Keywords

Wearable resistance vest; Respiratory muscle training; Maximal inspiratory pressure; Maximal expiratory pressure; Thoracic loading

Outcome Measures

Primary Outcomes (1)

• Maximum Inspiratory Pressure and Maximum Expiratory Pressure

  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

Study Arms (1)

One group, single arm study

EXPERIMENTAL

Participants wore the vest

Device: Wearable Resistance Vest

Interventions

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.

One group, single arm study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male and those participant were recruited from a university setting via convenience sampling.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Mecca Region, 23717, Saudi Arabia

Location

Study Officials

• Husam I Alahmadi, PhD

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This is a single-arm, prospective investigation where all participants received the same intervention. Each participant served as his own control, with respiratory muscle strength measured at baseline and then at weekly intervals (Week 1, Week 2, and Week 3) to evaluate the physiological response to the intervention over time.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 13, 2026
• Study Start: February 2, 2025
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

SA (1)