Effect of Breather in COPD Patients with Intermittent Claudication
NCT ID: NCT06529185
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-07-30
2025-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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treatment group
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.
The BREATHER
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
control group
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).
pharmacological treatment
patient will receive the usually pharmacological treatment.
Interventions
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The BREATHER
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 treatment
patient will receive the usually pharmacological treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Recent myocardial infarction,
* heart failure,
* arrhythmia,
* DVT,
* Intracranial hypertension,
* Pneumonia,
* kidney failure,
* fractures,
* uncooperative patients,
* cognitive impairment preventing a patient from participation in exercises.
50 Years
60 Years
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Reem Medhat Mohamed Ali Farahat
demonstrator
Principal Investigators
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Zahra M Serry, Assist.Prof
Role: STUDY_DIRECTOR
Cairo University
MARWA M ELSAYED, Assist.Prof
Role: STUDY_DIRECTOR
Cairo University
Amira I Almeldin, Assist.Prof
Role: STUDY_DIRECTOR
Cairo University
reem M farahat, student
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of Physical Therapy
Dokki, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Reem Farahat, master
Role: primary
References
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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.
Pinto 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.
Terzikhan 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.
Other Identifiers
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Breather on COPD with IC
Identifier Type: -
Identifier Source: org_study_id