Chronic Obstructive Pulmonary DiseaseNCT06172946
Effect of Powerbreath Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
A study testing powerbreath and TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- powerbreath and TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient selection will be according to the following criteria:
- Male patients diagnosed with stage 2\&3 COPD.
- All patients are under full medical control.
- Their ages will range from forty-five to sixty-five years.
- Patients with BMI from 25-29.9 kg/m2
Who cannot join
- Patients with the following criteria will be excluded from the study:
- Lack of language or cognitive abilities to fill out questionnaire.
- Patients with cardiac pacemaker.
- Contraindications for inspiratory muscle training (e.g. a history of recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, other serious lung disease).
- Existing arterial aneurysm.
- Clinical signs of unstable cardiac event (eg. congestive heart failure).
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- Patients with malignant disease.
- Acute COPD exacerbation within the last 4 weeks.
- Any need for supplemental oxygen.
- Patients with Gastro-esophageal reflux disease.
- Patients with active Hemoptysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke.
POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients.
Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).
Read the detailed description
sixty Patients will be assigned randomly into two equal groups with pre and post treatment protocol application.
Group A:
Thirty patients will be treated by power breathe along with their prescribed medication.
Group B:
Thirty patients will be treated by Transcutaneous electrical Diaphragmatic Stimulation (TEDS) along with their prescribed medication.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- powerbreath, TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION
- 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.
powerbreathDevice
Previous studies have confirmed the efficacy of implementing IMT as part of a RR program in a certain profile of patients with COPD, showing improvements in maximum inspiratory pressure, perception of well-being, and other respiratory diseases, and dyspnea during exercise. (Gandullo et al., 2022)
TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATIONDevice
Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscle weakness. A previous study reported that patients with chronic obstructive pulmonary disease (COPD) showed increased lung volume and oxygen saturation after a single session of TEDS. (Hsin et al., 2022)
| Study group | Role | What they receive |
|---|---|---|
| INSPIRATORY MUSCLE TRAINING | Experimental | Power Breathe:
(3times/week for 8 weeks) The patient should inhale and exhale through the mouthpiece 30 times maximum. The training load is adjustable and should be set at a level appropriate for the patient to effectively train the inspiratory muscles. (Lázaro et al., 2021) Receives: Device: powerbreath |
| TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION | Active comparator | Transcutaneous electrical Diaphragmatic Stimulation(TEDS):
(3times/week for 8 weeks) During each session, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. The electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. TEDS intensity was gradually increased until visible muscle contraction was observed. (Hsin et al., 2022) Receives: Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
The COPD Assessment Test (CAT)
The COPD Assessment Test(CAT) is validated questionnaire consisting of eight items, which evaluate the most burdensome symptoms and limitations of the patients. The score for each item ranges from 0 to 5 and the total score (0-40)
Measured: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks
Secondary outcomes (7)
Pulmonary function: By Spirometry Device:
- Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)
Measured: Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
- Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second (FEV1)
Measured: Pulmonary function: By Spirometry Device: forced expiratory volume in one second will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
- Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory volume in one second/forced expiratory volume (FEV1/FVC)
Measured: Pulmonary function: By Spirometry Device: forced expiratory volume in one second/forced expiratory volume will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
- Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced expiratory floe(FEF25-75%)
Measured: Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks
Diaphragmatic Thickness: By Ultrasonography:
- Diaphragmatic Thickness: By Ultrasonography: provides a simple and non-invasive means of assessing diaphragmatic function. (Boussuges et al., 2020)
Measured: Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks
Measuring functional capacity: By Six-minute walk test (6MWT):
- Measuring functional capacity: By Six-minute walk test (6MWT): is a self paced submaximal field exercise test , It will be performed according to the standard procedure is administered in a 30 meter hallway. (Launois et al., 2012 and ATS statement2002)
Measured: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks
Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):
- Dyspnea: By Modified Medical Research Council dyspnea scale (mMRC dyspnea scale): It is a 5 point scale based on degrees of variable physical activities that precipitate dyspnea with a score ranging from 0 to 4. (Richards, 2017)
Measured: Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start12 Dec 2023
- Primary completion25 Mar 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed El-Moatasem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172946
- Sponsor's protocol ID
- P.T.REC/012/004626
- Status last verified
- Feb 2025
- First submitted
- 3 Dec 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd
- ClinicalTrials.gov ID
- NCT06172946
- Acronym / sponsor ID
- P.T.REC/012/004626
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 15 Dec 2023 (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.
Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke.
POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients.
Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).
Detailed description
sixty Patients will be assigned randomly into two equal groups with pre and post treatment protocol application.
Group A:
Thirty patients will be treated by power breathe along with their prescribed medication.
Group B:
Thirty patients will be treated by Transcutaneous electrical Diaphragmatic Stimulation (TEDS) along with their prescribed medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INSPIRATORY MUSCLE TRAINING | Experimental | Device: powerbreathPower Breathe: (3times/week for 8 weeks) The patient should inhale and exhale through the mouthpiece 30 times maximum. The training load is adjustable and should be set at a level appropriate for the patient to effectively train the inspiratory muscles. (Lázaro et al., 2021) |
| TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION | Active comparator | Device: TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATIONTranscutaneous electrical Diaphragmatic Stimulation(TEDS): (3times/week for 8 weeks) During each session, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. The electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. TEDS intensity was gradually increased until visible muscle contraction was observed. (Hsin et al., 2022) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient selection will be according to the following criteria:
Key exclusion criteria (11 listed)
- Patients with the following criteria will be excluded from the study:
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 |
|---|---|---|
| powerbreathPrevious studies have confirmed the efficacy of implementing IMT as part of a RR program in a certain profile of patients with COPD, showing improvements in maximum inspiratory pressure, perception of well-being, and other respiratory diseases, and dyspnea during exercise. (Gandullo et al., 2022) | Device | INSPIRATORY MUSCLE TRAINING |
| TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATIONTranscutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscle weakness. A previous study reported that patients with chronic obstructive pulmonary disease (COPD) showed increased lung volume and oxygen saturation after a single session of TEDS. (Hsin et al., 2022) | Device | TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION |
Primary outcome
The COPD Assessment Test (CAT)
Time frame: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks
The COPD Assessment Test(CAT) is validated questionnaire consisting of eight items, which evaluate the most burdensome symptoms and limitations of the patients. The score for each item ranges from 0 to 5 and the total score (0-40)
7 secondary outcomes
Pulmonary function: By Spirometry Device:
Time frame: Pulmonary function: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
Time frame: Pulmonary function: By Spirometry Device: forced expiratory volume in one second will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
Time frame: Pulmonary function: By Spirometry Device: forced expiratory volume in one second/forced expiratory volume will be measured at baseline, and it will be measured again after eight weeks
Pulmonary function: By Spirometry Device:
Time frame: Pulmonary function: By Spirometry Device: forced expiratory flow will be measured at baseline, and it will be measured again after eight weeks
Diaphragmatic Thickness: By Ultrasonography:
Time frame: Diaphragmatic Thickness: By Ultrasonography:will be measured at baseline, and it will be measured again after eight weeks
Measuring functional capacity: By Six-minute walk test (6MWT):
Time frame: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after eight weeks
Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):
Time frame: Modified Medical Research Council dyspnea scale (mMRC dyspnea scale):will be measured at baseline, and it will be measured again after eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powerbreath and TRANSCUTANEOUS ELECTRICAL DIAPHRAGMATIC STIMULATION in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
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 11 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The COPD Assessment Test (CAT) (time frame: COPD Assessment Test will be measured at baseline, and it will be measured again after eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.