Effect of Breather in COPD Patients with Intermittent Claudication

Cairo University (CU)

Status: Enrolling

Conditions: PAD; COPD

Treatments: Drug: pharmacological treatment; Device: The BREATHER

Study type: Interventional

Funder types: Other

Identifiers

NCT06529185

Breather on COPD with IC

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

treatment group

Experimental group

Description:

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.

Treatment:

Device: The BREATHER

control group

Active Comparator group

Description:

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).

Treatment:

Drug: pharmacological treatment