Digital High-Intensity Respiratory Muscle Training on COPD Patients (NCT07346261) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digital High-Intensity Respiratory Muscle Training on COPD Patients
60 participantsStarted 2026-01-20
Plain-language summary
The goal of this Randomize control trail is to determine the effect of Digital High-Intensity Respiratory Muscle Training on ventilatory Function and Functional Capacity in Patients with COPD It will also learn about the safety and tolerability of this digital training program.
The main questions it aims to answer are: Does digital high-intensity respiratory muscle training improve inspiratory and expiratory muscle strength (MIP and MEP)? ,Does it improve functional exercise capacity (6-minute walk distance) and lung function (FEV₁, FVC, FEV₁/FVC)?
Who can participate
Age range
50 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV)
. FEV₁ \> 80% of predicted.
. Age 50-65 years.
. Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold).
. Clinically stable with no acute exacerbations.
Exclusion criteria
. Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ventilatory function measures (FVC, FEV1, and FEV1/FVC)
Timeframe: twice, first before beginning treatment from day 1 of treatment second after complete treatment after 2 months ,Assessment will be for 5 minutes for ventilatory function
2
Functional capacity by 6MWT
Timeframe: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute
. Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease).
. Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures.
. Cognitive impairment or psychiatric illness that affects cooperation.
. Participation in another clinical trial or intervention within the last 3 months.
. Current use of any other respiratory muscle training device or app.