Digital High-Intensity Respiratory Muscle Training on COPD Patients

Cairo University (CU)

Status: Not yet enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Other: conventional respiratory rehabilitation; Device: Digital Sonmol Respiratory Muscle Trainer

Study type: Interventional

Funder types: Other

Identifiers

NCT07346261

P.T.REC/012/006187

Details and patient eligibility

About

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)?

Full description

This single-blinded randomized controlled trial is to determine effect of Digital High-intensity Respiratory Muscle Training delivered through the Sonmol electronic respiratory muscle trainer on ventilatory function and functional capacity in patients with chronic obstructive pulmonary diseases (COPD)

It articulates the clinical rationale by explaining how airflow limitation is caused by COPD and chest hyperinflation, or dysfunction of respiratory muscles, and describes why specific, intense exercise training of muscles of inspiration or expiration may correct or prevent these conditions.

This trial within current evidence supporting respiratory-muscle training and highlights the potential advantages of digital delivery-real-time feedback, adjustable resistance, gamification, and remote monitoring-to boost adherence and training specificity in a rehabilitation context.

The study compares digital high-intensity respiratory muscle training plus conventional pulmonary rehabilitation to conventional pulmonary rehabilitation alone to see if the digital training provides additional benefits.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV)
2. FEV₁ > 80% of predicted.
3. Age 50-65 years.
4. Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold).
5. Clinically stable with no acute exacerbations.

Exclusion criteria

1. Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension).
2. Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease).
3. Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures.
4. Cognitive impairment or psychiatric illness that affects cooperation.
5. Participation in another clinical trial or intervention within the last 3 months.
6. Current use of any other respiratory muscle training device or app.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A (study group)

Experimental group

Description:

30 patient who will receive high-intensity respiratory training with the digital Sonmol Respiratory Muscle Trainer for 15 to 20 Minutes, in addition to a conventional pulmonary rehabilitation program for 25 to 30 Minutes, with a total duration of 50 to 60 minutes for each session. , 3 sessions/week, for 8 weeks.

Treatment:

Device: Digital Sonmol Respiratory Muscle Trainer

Other: conventional respiratory rehabilitation

Group B (control group)

Experimental group

Description:

30 patient who will receive the conventional pulmonary rehabilitation program for 25 to 30 minutes for each session, 3 sessions / week, for 8 weeks.

Treatment:

Other: conventional respiratory rehabilitation