COPDNCT06529185
Effect of Breather in COPD Patients With Intermittent Claudication
A study testing The BREATHER and pharmacological treatment in people with COPD and PAD, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- What is being tested?
- The BREATHER and pharmacological treatment
- 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
- 30 Jul 2024to Feb 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- sixty male patients with diagnosed with grade I and grade II COPD their ages ranged between 55-60years
- All patients will be clinically and medically stable when attending the study.
- Body mass index (BMI) is 18.5 to 24.9 kg/m2.
- History of unilateral exertional leg pain,
- Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the fontaine classification of pad),
- And an ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise.
Who cannot join
- cardiovascular insufficiency,
- Recent myocardial infarction,
- heart failure,
- arrhythmia,
- DVT,
- Intracranial hypertension,
Show all 11Show fewer
- Pneumonia,
- kidney failure,
- fractures,
- uncooperative patients,
- cognitive impairment preventing a patient from participation in exercises.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Dokki
Reem Farahat, master
About this study
Official title: Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication.
The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.
Read the detailed description
recent researches show that COPD patients have risk of developing peripheral arterial disease (PAD) which represented on patient by intermittent claudication inspiratory muscle trainer as the breather device show increasing in inspiratory muscle strength and endurance; reduction of dyspnea; and improving of exercise tolerance .
Because of all this things this study tends to show the effect of the breather on ventilatory and vascular function in COPD patient with intermittent claudication.
- Being tested
- The BREATHER, pharmacological treatment
- 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.
The BREATHERDevice
Also called experimental group
The BREATHER is Light/Medium resistance inspiratory muscle trainer which has significance role in increasing inspiratory muscle strength and endurance which could result in a decreased sensation of dyspnea
pharmacological treatmentDrug
Also called control group
patient will receive the usually pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | This group include 30 patients with COPD and intermittent claudication. These patients can receive aerobic exercise (by applying treadmill exercise for 20 min) and inspiratory muscle training (by using The BREATHER device with Light/Medium resistance for 3-5 sets /session), for 4 weeks (3 sessions per week) and pursed lip breathing. Receives: Device: The BREATHER |
| control group | Active comparator | This group include 30 patients with COPD and intermittent claudication. These patients can receive pursed lip breathing and aerobic exercise (by applying treadmill exercise for 20 min) with the usually pharmacological treatment, for 4 weeks (3 sessions per week). Receives: Drug: pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory function: by spirometry test
Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.
Measured: 4 weeks
Vascular function: by doppler ultrasound
Doppler ultrasound is a simple and non-invasive and method for the evaluation of early atherosclerosis. It can be used as a screening program for PAD in populations with high risk for atherosclerosis.
Measured: 4 weeks
Secondary outcomes (2)
Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)
(5R-STS) test is an objective test of functional impairment commonly used in various diseases including COPD which is used to measure the severity of disease and to monitor recovery.
Measured: 4 weeks
Treadmill exercise testing
The results of the tests will be expressed in units of distance that will be walked up to the claudication pain (initial claudication distance) and the maximally tolerated claudication pain (maximal claudication distance).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Jul 2024
- Primary completion20 Dec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Medhat Mohamed Ali Farahat, Cairo University
- Investigators
- Zahra M Serry, Assist.Prof, Study director, Cairo UniversityMARWA M ELSAYED, Assist.Prof, Study director, Cairo UniversityAmira I Almeldin, Assist.Prof, Study director, Cairo Universityreem M farahat, student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529185
- Sponsor's protocol ID
- Breather on COPD with IC
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beaumont M, Forget P, Couturaud F, Reychler G. Effects of inspiratory muscle training in COPD patients: A systematic review and meta-analysis. Clin Respir J. 2018 Jul;12(7):2178-2188. doi: 10.1111/crj.12905. Epub 2018 May 23.
PubMed 29665262Pinto B, Correia MV, Paredes H, Silva I. Detection of Intermittent Claudication from Smartphone Inertial Data in Community Walks Using Machine Learning Classifiers. Sensors (Basel). 2023 Feb 1;23(3):1581. doi: 10.3390/s23031581.
PubMed 36772621Terzikhan N, Lahousse L, Verhamme KMC, Franco OH, Ikram AM, Stricker BH, Brusselle GG. COPD is associated with an increased risk of peripheral artery disease and mortality. ERJ Open Res. 2018 Dec 21;4(4):00086-2018. doi: 10.1183/23120541.00086-2018. eCollection 2018 Oct.
PubMed 30588480Elsayed MM, Farahat RM, Serry ZH, Almeldin AI. Inspiratory Muscle Training and Aerobic Exercise Affect Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication: A Randomized Controlled Trial. Physiother Res Int. 2026 Jan;31(1):e70130. doi: 10.1002/pri.70130.
PubMed 41287032
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication.
- ClinicalTrials.gov ID
- NCT06529185
- Acronym / sponsor ID
- Breather on COPD with IC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 Jul 2024 (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 aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.
Detailed description
recent researches show that COPD patients have risk of developing peripheral arterial disease (PAD) which represented on patient by intermittent claudication inspiratory muscle trainer as the breather device show increasing in inspiratory muscle strength and endurance; reduction of dyspnea; and improving of exercise tolerance .
Because of all this things this study tends to show the effect of the breather on ventilatory and vascular function in COPD patient with intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: The BREATHERThis group include 30 patients with COPD and intermittent claudication. These patients can receive aerobic exercise (by applying treadmill exercise for 20 min) and inspiratory muscle training (by using The BREATHER device with Light/Medium resistance for 3-5 sets /session), for 4 weeks (3 sessions per week) and pursed lip breathing. |
| control group | Active comparator | Drug: pharmacological treatmentThis group include 30 patients with COPD and intermittent claudication. These patients can receive pursed lip breathing and aerobic exercise (by applying treadmill exercise for 20 min) with the usually pharmacological treatment, for 4 weeks (3 sessions per week). |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- sixty male patients with diagnosed with grade I and grade II COPD their ages ranged between 55-60years
- All patients will be clinically and medically stable when attending the study.
- Body mass index (BMI) is 18.5 to 24.9 kg/m2.
- History of unilateral exertional leg pain,
- Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the fontaine classification of pad),
Key exclusion criteria (11 listed)
- cardiovascular insufficiency,
- Recent myocardial infarction,
- heart failure,
- arrhythmia,
- DVT,
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 |
|---|---|---|
| The BREATHERAlso: experimental groupThe BREATHER is Light/Medium resistance inspiratory muscle trainer which has significance role in increasing inspiratory muscle strength and endurance which could result in a decreased sensation of dyspnea | Device | treatment group |
| pharmacological treatmentAlso: control grouppatient will receive the usually pharmacological treatment. | Drug | control group |
Primary outcome
Ventilatory function: by spirometry test
Time frame: 4 weeks
Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.
Vascular function: by doppler ultrasound
Time frame: 4 weeks
Doppler ultrasound is a simple and non-invasive and method for the evaluation of early atherosclerosis. It can be used as a screening program for PAD in populations with high risk for atherosclerosis.
2 secondary outcomes
Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)
Time frame: 4 weeks
Treadmill exercise testing
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Results publication: PubMed 29665262Beaumont M, Forget P, Couturaud F, Reychler G. Effects of inspiratory muscle training in COPD patients: A systematic review and meta-analysis. Clin Respir J. 2018 Jul;12(7):2178-2188. doi: 10.1111/crj.12905. Epub 2018 May 23.
- Results publication: PubMed 36772621Pinto B, Correia MV, Paredes H, Silva I. Detection of Intermittent Claudication from Smartphone Inertial Data in Community Walks Using Machine Learning Classifiers. Sensors (Basel). 2023 Feb 1;23(3):1581. doi: 10.3390/s23031581.
- Results publication: PubMed 30588480Terzikhan N, Lahousse L, Verhamme KMC, Franco OH, Ikram AM, Stricker BH, Brusselle GG. COPD is associated with an increased risk of peripheral artery disease and mortality. ERJ Open Res. 2018 Dec 21;4(4):00086-2018. doi: 10.1183/23120541.00086-2018. eCollection 2018 Oct.
- Derived from this study: PubMed 41287032Elsayed MM, Farahat RM, Serry ZH, Almeldin AI. Inspiratory Muscle Training and Aerobic Exercise Affect Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication: A Randomized Controlled Trial. Physiother Res Int. 2026 Jan;31(1):e70130. doi: 10.1002/pri.70130.
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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.
Zahra M Serry, Assist.Prof study director
Cairo University
MARWA M ELSAYED, Assist.Prof study director
Cairo University
Amira I Almeldin, Assist.Prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BREATHER and pharmacological treatment in people with COPD and PAD, 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 6 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: status not confirmed, as of the sponsor's last update on 31 Dec 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem M Farahat, student (+201050770870, Reemfarahat42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory function: by spirometry test (time frame: 4 weeks). 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 NCT06529185, which also lists 4 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 31 Dec 2024.