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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 range50 Years – 60 Years

SexALL

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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).
✕. 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.

What they're measuring

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

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

Trial details

NCT IDNCT07346261

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-20

Contact for this trial

Hagar M. Waly, Bachelor of physical therapy

+20 1006954164 10722023423465@pg.cu.edu.eg

View on ClinicalTrials.gov More COPD (Chronic Obstructive Pulmonary Disease) trials