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Effect of Breather in COPD Patients with Intermittent Claudication

Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients with Intermittent Claudication.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06529185
Enrollment
60
Registered
2024-07-31
Start date
2024-07-30
Completion date
2025-02-28
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, PAD

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.

Interventions

DEVICEThe 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

patient will receive the usually pharmacological treatment.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventilatory function: by spirometry test4 weeksSpirometry is a physiological test that measures the ability to inhale and exhale air relative to time.
Vascular function: by doppler ultrasound4 weeksDoppler 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

MeasureTime frameDescription
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 testing4 weeksThe 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).

Countries

Egypt

Contacts

Primary ContactReem M Farahat, student
Reemfarahat42@gmail.com+201050770870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026