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Digital High-Intensity Respiratory Muscle Training on COPD Patients

NCT07346261 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-21

No results posted yet for this study

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)?

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DEVICE

Digital Sonmol Respiratory Muscle Trainer

The patient will be asked to inhale deeply and forcefully for approximately two to three seconds and have a pause of slightly under a second. Then exhale out of the device and rest for 30 to 60 seconds and will be done for 2 sets of ten breaths, two times per day, for eight weeks The resistance will increase about 10 % to 15 % every week according to patient status in addition to a conventional respiratory rehabilitation program for 25 to 30 Minutes, with a total duration of 50 to 60 minutes for each session.

OTHER

conventional respiratory rehabilitation

The patients will receive conventional respiratory Rehabilitation in the form of Diaphragmatic breathing exercise for 5 to 10 minutes and Localized Breathing for lower, middle, and upper segments for 10 to 15 minutes, total session time 25 to 30 minutes for two to four sessions daily for 3 days/ week for 8 weeks

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-03-20
Completion
2026-04-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346261 on ClinicalTrials.gov