Respiratory Muscle TrainingNCT06230692
Diaphragm Structure and Function in Children
A study testing POWERbreathe Plus IMT in people with Respiratory Muscle Training, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Training
- What is being tested?
- POWERbreathe Plus IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2024to 6 Jan 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range 6-12 years of age
Who cannot join
- History of neuromuscular, cardiac, or pulmonary disease
- Known intellectual or developmental problems that would preclude the ability to assent
- Ruptured eardrum
- Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
- Recent (less than 2 weeks ago) or current respiratory or other type of illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children
The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.
Read the detailed description
During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.
- Conditions
- Respiratory Muscle Training
- Being tested
- POWERbreathe Plus IMT
- Keywords
- Diaphragm, Control of Breathing, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERbreathe Plus IMTDevice
Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O.
During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home. Receives: Device: POWERbreathe Plus IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent completion
Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol
Measured: 6 weeks
Adherence to treatment protocol
Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol
Measured: 6 weeks
Secondary outcomes (3)
Maximal inspiratory pressure (measured in cm H2O)
Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength
Measured: 6 weeks
Diaphragm thickness (measured in mm)
Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging
Measured: 6 weeks
Exercise ventilation
Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start16 Mar 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Muscle TrainingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Ho, University of Maryland, Baltimore
- Investigators
- Simon Ho, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230692
- Sponsor's protocol ID
- HP-00108839
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho S, Marchese V. Differential effects of inspiratory muscle training on diaphragm thickness and exercise tolerance in childhood cancer survivors and non-cancer controls. Front Pediatr. 2026 Apr 10;14:1810953. doi: 10.3389/fped.2026.1810953. eCollection 2026.
PubMed 42038239
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children
- ClinicalTrials.gov ID
- NCT06230692
- Acronym / sponsor ID
- HP-00108839
- Conditions
- Respiratory Muscle Training
- Keywords
- Diaphragm, Control of Breathing, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 30 Jan 2024 (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.
The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.
Detailed description
During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Device: POWERbreathe Plus IMTParticipants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age range 6-12 years of age
Key exclusion criteria (5 listed)
- History of neuromuscular, cardiac, or pulmonary disease
- Known intellectual or developmental problems that would preclude the ability to assent
- Ruptured eardrum
- Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
- Recent (less than 2 weeks ago) or current respiratory or other type of illness
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 |
|---|---|---|
| POWERbreathe Plus IMTInspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O. During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks. | Device | Inspiratory Muscle Training (IMT) |
Primary outcome
Percent completion
Time frame: 6 weeks
Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol
Adherence to treatment protocol
Time frame: 6 weeks
Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol
3 secondary outcomes
Maximal inspiratory pressure (measured in cm H2O)
Time frame: 6 weeks
Diaphragm thickness (measured in mm)
Time frame: 6 weeks
Exercise ventilation
Time frame: 6 weeks
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 30 Mar 2026.
- Derived from this study: PubMed 42038239Ho S, Marchese V. Differential effects of inspiratory muscle training on diaphragm thickness and exercise tolerance in childhood cancer survivors and non-cancer controls. Front Pediatr. 2026 Apr 10;14:1810953. doi: 10.3389/fped.2026.1810953. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Simon Ho principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERbreathe Plus IMT in people with Respiratory Muscle Training, run by University of Maryland, Baltimore at 1 site in United States.
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 5 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 30 Mar 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 United States. 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?
Percent completion (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230692, which also lists 1 linked publication.
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 30 Mar 2026.