Actively Recruiting

Phase Not Applicable
Age: 50Years - 60Years
MALE
ID06529185

Effect of The BREATHER Device on Breathing and Blood Vessel Function in Men with COPD and Intermittent Claudication

Led by Cairo University · Updated on 2024-12-31

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial investigates the effect of the Breather device on breathing and blood vessel function in male patients aged 55 to 60 with chronic obstructive pulmonary disease (COPD) and intermittent claudication caused by peripheral arterial disease (PAD). Research shows that COPD patients are at risk of developing PAD, which causes leg pain during walking. The Breather is an inspiratory muscle trainer that may improve breathing muscle strength, reduce breathlessness, and enhance exercise tolerance in these patients. Participants will receive treatment with the Breather device, which provides light to medium resistance to strengthen breathing muscles and potentially decrease breathlessness. They will also continue their usual pharmacological treatments. The study focuses on evaluating how this device affects breathing and vascular function. During the study, participants will undergo tests including spirometry to measure lung function and Doppler ultrasound to assess blood vessel function after four weeks of using the Breather. Researchers will monitor these outcomes to understand the device's impact on breathing and circulation. The study includes 60 male patients who are clinically stable and meet specific criteria related to COPD severity, body weight, and symptoms of intermittent claudication.

CONDITIONS

Official Title

Effect of Breather in COPD Patients With Intermittent Claudication

Who Can Participate

Age: 50Years - 60Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 55 to 60 years diagnosed with grade I or grade II COPD
  • Clinically and medically stable at study entry
  • Body mass index (BMI) between 18.5 and 24.9 kg/m2
  • History of unilateral exertional leg pain
  • Limited walking ability due to leg pain consistent with intermittent claudication (stage II of the Fontaine classification of PAD)
  • Ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise
Not Eligible

You will not qualify if you...

  • Cardiovascular insufficiency
  • Recent myocardial infarction
  • Heart failure
  • Arrhythmia
  • Deep vein thrombosis (DVT)
  • Intracranial hypertension
  • Pneumonia
  • Kidney failure
  • Bone fractures
  • Uncooperative patients
  • Cognitive impairment preventing participation in exercises

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Physical Therapy

Dokki, Egypt

Actively Recruiting

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Research Team

R

Reem M Farahat, student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Detection of Intermittent Claudication from Smartphone Inertial Data in Community Walks Using Machine Learning Classifiers.

Bruno Pinto, Miguel Velhote Correia, Hugo Paredes...

https://pubmed.ncbi.nlm.nih.gov/36772621

Inspiratory Muscle Training and Aerobic Exercise Affect Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication: A Randomized Controlled Trial.

Marwa M Elsayed, Reem M Farahat, Zahra H Serry...

https://pubmed.ncbi.nlm.nih.gov/41287032