Effect of Breather in COPD Patients With Intermittent Claudication

Not Applicable

Recruiting

• Conditions: PAD; COPD
• Interventions: Device: The BREATHER; Drug: pharmacological treatment

• Registration Number: NCT06529185
• Lead Sponsor: Cairo University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study Start: 2024-07-30
• Study First Posted: 2024-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2024-12-20
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Fourty male patients with diagnosed with grade I and grade II COPD their ages ranged between 45-55 years
• All patients will be clinically and medically stable when attending the study.
• Body mass index (BMI) is 25 - 29.9 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.

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Exclusion Criteria

• cardiovascular insufficiency,
• Recent myocardial infarction,
• heart failure,
• arrhythmia,
• DVT,
• Intracranial hypertension,
• Pneumonia,
• kidney failure,
• fractures,
• uncooperative patients,
• cognitive impairment preventing a patient from participation in exercises.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	The BREATHER	This group include 20 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	pharmacological treatment	This group include 20 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).

Primary Outcome Measures

Name	Time	Method
Ventilatory function: by spirometry test	4 weeks	Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.
Vascular function: by doppler ultrasound	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.

Secondary Outcome Measures

Name	Time	Method
Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)	4 weeks	(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.
Treadmill exercise testing	4 weeks	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).

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Dokki, Egypt