Effect of Breather in COPD Patients With Intermittent Claudication

ConditionsCOPDPAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-60
SponsorCairo University

About this trial

The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

cardiovascular insufficiency,

Recent myocardial infarction,

heart failure,

arrhythmia,

Trial design

Design model

Parallel

Treatments tested in this trial

  • The BREATHER

    Device

    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

    Drug

    patient will receive the usually pharmacological treatment.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: treatment groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilatory function: by spirometry test

Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Secondary outcomes

1

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.

Time frame
4 weeks
2

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).

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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