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NCT Number: NCT07346261

Digital High-Intensity Respiratory Muscle Training on COPD Patients

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)?

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Sonmol Respiratory Muscle Trainer

Device

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.

conventional respiratory rehabilitation

Other

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

Primary outcomes

  1. 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

  2. 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,

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hagar M. Waly, Bachelor of physical therapy

CONTACT

[email protected]

+20 1006954164

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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