COPD (Chronic Obstructive Pulmonary Disease)COPDNCT07346261
Digital High-Intensity Respiratory Muscle Training on COPD Patients
A study testing Digital Sonmol Respiratory Muscle Trainer and conventional respiratory rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease), run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Digital Sonmol Respiratory Muscle Trainer and conventional respiratory rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)?
Read the 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.
- Being tested
- Digital Sonmol Respiratory Muscle Trainer, conventional respiratory rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Sonmol Respiratory Muscle TrainerDevice
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 rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (study group) | Experimental | 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. Receives: Device: Digital Sonmol Respiratory Muscle Trainer; Other: conventional respiratory rehabilitation |
| Group B (control group) | Experimental | 30 patient who will receive the conventional pulmonary rehabilitation program for 25 to 30 minutes for each session, 3 sessions / week, for 8 weeks. Receives: Other: conventional respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory function measures (FVC, FEV1, and FEV1/FVC)
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
Measured: 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
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,
Measured: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute
Secondary outcomes (2)
Respiratory muscle strength (MIP and MEP).
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.
Measured: 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
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
Measured: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 4 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Waly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346261
- Sponsor's protocol ID
- P.T.REC/012/006187
- Acronym
- COPD
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lin TK, Chen MY, Cheng HH, Chow J, Chen CM, Chou W. Effectiveness of abdominal sandbag training in enhancing diaphragm muscle function and exercise tolerance in patients with chronic respiratory failure. J Formos Med Assoc. 2024 Oct;123(10):1087-1092. doi: 10.1016/j.jfma.2024.01.021. Epub 2024 Feb 1.
PubMed 38302365• World Health Organization. (2024, November 6). Chronic obstructive pulmonary disease (COPD). Retrieved June 22, 2025, from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
Jing Y, Ma Y, Zhang H, Wu Z, Li Y, Li H, Huang M, Lin L, Xu Y. Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial. Trials. 2023 Jan 30;24(1):69. doi: 10.1186/s13063-022-07058-2.
PubMed 36717916Han B, Chen Z, Ruan B, Chen Y, Lv Y, Li C, Yu L. Effects of Inspiratory Muscle Training in People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Life (Basel). 2024 Nov 12;14(11):1470. doi: 10.3390/life14111470.
PubMed 39598268Furukawa Y, Miyamoto A, Asai K, Tsutsumi M, Hirai K, Ueda T, Toyokura E, Nishimura M, Sato K, Yamada K, Watanabe T, Kawaguchi T. Respiratory Muscle Strength as a Predictor of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease. Respirology. 2025 May;30(5):408-416. doi: 10.1111/resp.70003. Epub 2025 Feb 26.
PubMed 40009650Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.
PubMed 36070636Chen Q, Wu X, Huang Y, Chen L. Internet of Things-Based Home Respiratory Muscle Training for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2024 May 22;19:1093-1103. doi: 10.2147/COPD.S454804. eCollection 2024.
PubMed 38800522Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023.
PubMed 37682839Barata PI, Crisan AF, Maritescu A, Negrean RA, Rosca O, Bratosin F, Citu C, Oancea C. Evaluating Virtual and Inpatient Pulmonary Rehabilitation Programs for Patients with COPD. J Pers Med. 2022 Oct 25;12(11):1764. doi: 10.3390/jpm12111764.
PubMed 36573730• Atef Mohamed, N., Abd Elkader Ahmed, M., & Awadeen, L. (2023). Assessment of quality of life for patients with chronic obstructive pulmonary disease in the outpatient clinic at Beni-Suef University Hospital. Egyptian Journal of Health Care, 14(4), 554-577
Aburub A, Darabseh MZ, Badran R, Eilayyan O, Shurrab AM, Degens H. The Effects of Digital Health Interventions for Pulmonary Rehabilitation in People with COPD: A Systematic Review of Randomized Controlled Trials. Medicina (Kaunas). 2024 Jun 11;60(6):963. doi: 10.3390/medicina60060963.
PubMed 38929580
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Digital High-Intensity Respiratory Muscle Training on Ventilatory Function and Functional Capacity in Patients With COPD
- ClinicalTrials.gov ID
- NCT07346261
- Acronym / sponsor ID
- COPD / P.T.REC/012/006187
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (study group) | Experimental | Device: Digital Sonmol Respiratory Muscle Trainer, Other: conventional respiratory rehabilitation30 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. |
| Group B (control group) | Experimental | Other: conventional respiratory rehabilitation30 patient who will receive the conventional pulmonary rehabilitation program for 25 to 30 minutes for each session, 3 sessions / week, for 8 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Sonmol Respiratory Muscle TrainerThe 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. | Device | Group A (study group) |
| conventional respiratory rehabilitationThe 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 | Other | Group A (study group), Group B (control group) |
Primary outcome
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
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,
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 38302365Lin TK, Chen MY, Cheng HH, Chow J, Chen CM, Chou W. Effectiveness of abdominal sandbag training in enhancing diaphragm muscle function and exercise tolerance in patients with chronic respiratory failure. J Formos Med Assoc. 2024 Oct;123(10):1087-1092. doi: 10.1016/j.jfma.2024.01.021. Epub 2024 Feb 1.
- Background• World Health Organization. (2024, November 6). Chronic obstructive pulmonary disease (COPD). Retrieved June 22, 2025, from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
- Background: PubMed 36717916Jing Y, Ma Y, Zhang H, Wu Z, Li Y, Li H, Huang M, Lin L, Xu Y. Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial. Trials. 2023 Jan 30;24(1):69. doi: 10.1186/s13063-022-07058-2.
- Background: PubMed 39598268Han B, Chen Z, Ruan B, Chen Y, Lv Y, Li C, Yu L. Effects of Inspiratory Muscle Training in People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Life (Basel). 2024 Nov 12;14(11):1470. doi: 10.3390/life14111470.
- Background: PubMed 40009650Furukawa Y, Miyamoto A, Asai K, Tsutsumi M, Hirai K, Ueda T, Toyokura E, Nishimura M, Sato K, Yamada K, Watanabe T, Kawaguchi T. Respiratory Muscle Strength as a Predictor of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease. Respirology. 2025 May;30(5):408-416. doi: 10.1111/resp.70003. Epub 2025 Feb 26.
- Background: PubMed 36070636Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.
- Background: PubMed 38800522Chen Q, Wu X, Huang Y, Chen L. Internet of Things-Based Home Respiratory Muscle Training for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2024 May 22;19:1093-1103. doi: 10.2147/COPD.S454804. eCollection 2024.
- Background: PubMed 37682839Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023.
- Background: PubMed 36573730Barata PI, Crisan AF, Maritescu A, Negrean RA, Rosca O, Bratosin F, Citu C, Oancea C. Evaluating Virtual and Inpatient Pulmonary Rehabilitation Programs for Patients with COPD. J Pers Med. 2022 Oct 25;12(11):1764. doi: 10.3390/jpm12111764.
- Background• Atef Mohamed, N., Abd Elkader Ahmed, M., & Awadeen, L. (2023). Assessment of quality of life for patients with chronic obstructive pulmonary disease in the outpatient clinic at Beni-Suef University Hospital. Egyptian Journal of Health Care, 14(4), 554-577
- Background: PubMed 38929580Aburub A, Darabseh MZ, Badran R, Eilayyan O, Shurrab AM, Degens H. The Effects of Digital Health Interventions for Pulmonary Rehabilitation in People with COPD: A Systematic Review of Randomized Controlled Trials. Medicina (Kaunas). 2024 Jun 11;60(6):963. doi: 10.3390/medicina60060963.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Sonmol Respiratory Muscle Trainer and conventional respiratory rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease), run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar M. Waly, Bachelor of physical therapy (+20 1006954164, 10722023423465@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346261, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.