Healthy Adult MaleWEARVESTNCT07698873
Wearable Resistance Vest for Strengthening Respiratory Muscles
A study testing Wearable Resistance Vest in people with Healthy Adult Male, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Wearable Resistance Vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Feb 2025to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Adult Male
- Being tested
- Wearable Resistance Vest
- Keywords
- Wearable resistance vest, Respiratory muscle training, Maximal inspiratory pressure, Maximal expiratory pressure, Thoracic loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Resistance VestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| One group, single arm study | Experimental | Participants wore the vest Receives: Device: Wearable Resistance Vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Feb 2025
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Husam I. Alahmadi, King Abdulaziz University
- Investigators
- Husam I Alahmadi, PhD, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698873
- Sponsor's protocol ID
- HA-02J-008
- Acronym
- WEARVEST
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Wearable Resistance Vest for Strengthening Respiratory Muscles: A Proof-of-Concept Study in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT07698873
- Acronym / sponsor ID
- WEARVEST / HA-02J-008
- Conditions
- Healthy Adult Male
- Keywords
- Wearable resistance vest, Respiratory muscle training, Maximal inspiratory pressure, Maximal expiratory pressure, Thoracic loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| One group, single arm study | Experimental | Device: Wearable Resistance VestParticipants wore the vest |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Resistance VestA 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. | Device | One group, single arm study |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Husam I Alahmadi, PhD principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Resistance Vest in people with Healthy Adult Male, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure and Maximum Expiratory Pressure (time frame: Three Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.