Digital High-Intensity Respiratory Muscle Training on COPD Patients (COPD)

January 19, 2026 updated by: Hagar Waly, Cairo University

Impact of Digital High-Intensity Respiratory Muscle Training on Ventilatory Function and Functional Capacity in Patients With COPD

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)?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (study group)

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.
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
Experimental: Group B (control group)
30 patient who will receive the conventional pulmonary rehabilitation program for 25 to 30 minutes for each session, 3 sessions / week, for 8 weeks.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory function measures (FVC, FEV1, and FEV1/FVC)
Time Frame: 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

will be assessed by using Spirometry (smartSOFTmee version 2.14.21)

FVC (Forced Vital Capacity):

The maximum volume of air that a person can forcibly exhale after taking a full, deep inhalation. FEV₁ (Forced Expiratory Volume in 1 second):

The volume of air exhaled during the first second of the forced expiratory maneuver. FEV₁/FVC ratio:

The percentage of the total forced vital capacity exhaled in the first second, used to assess the presence of airflow obstruction.

After preparing the device and the patient and delivering instructions, each patient will assume the sitting position with a nose clip on the nose, they will asked to take a deep breath quickly, with a hold of more than one second at TLC, next, firmly seal the mouthpiece with the lips, then execute the FVC technique. Lastly, forcefully exhale for as long as he/she can and as quickly as feasible while loudly asking for more, more, more. This process should last for at least six seconds
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
Time Frame: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute
The 6MWT will be used to measure functional exercise capacity. The investigator measures blood pressure, heart rate, and oxygen saturation. The Patient wears clothing and footwear that are safe for testing. The walking surface will be hard and flat. Often, two cones are set up about 100 feet (30 meters) and the patient will walk back and forth between them for six minutes. At the end of the test, the investigator calculates the distance the patient walked in 6 minutes,
twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength (MIP and MEP).
Time Frame: twice, first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 3 minute
it will be used for assessment of respiratory muscle strength. Manometers are pressure reading devices used to measure positive and negative pressures objectively . One manometer developed specifically for maximal expiratory (MEP), and inspiratory (MIP) respiratory pressure testing is the Sonmol Digital Manometer Electric Version.
twice, first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 3 minute
Patient-reported outcomes by CAT score
Time Frame: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 4 minute
the CAT is a questionnaire that can assess the patient-reported outcomes and the effect of symptoms on COPD patients' lives. The CAT asks eight questions, prompting to assign a score ranging from 0 to 5 for each area A score of 0 means there's no impairment in that area. A score of 5 means severe impairment. The overall score will range from 0 to 40
twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 4 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/006187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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