Actively Recruiting

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

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

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

60

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of the Breather device on breathing and blood vessel function in men aged 55 to 60 years with chronic obstructive pulmonary disease (COPD) and intermittent claudication, a symptom of peripheral arterial disease (PAD) causing leg pain during walking. The study focuses on how using this inspiratory muscle trainer might improve muscle strength, reduce breathlessness, and increase exercise tolerance in these patients. Participants are randomly assigned to one of two groups for 4 weeks, with sessions held three times per week. One group receives aerobic exercise on a treadmill for 20 minutes, Breather device training with light to medium resistance for 3 to 5 sets per session, and pursed lip breathing. The other group receives usual pharmacological treatment along with pursed lip breathing and treadmill exercise for 20 minutes. This design allows comparison between the Breather device plus exercise and standard care with exercise. Throughout the study, participants undergo assessments that include spirometry tests to measure lung function and Doppler ultrasound to evaluate blood vessel function, both after 4 weeks. Functional capacity is tested using a sit-to-stand test and treadmill exercise testing. Researchers will monitor participants' respiratory and vascular responses to treatment. The total participation lasts for the 4-week treatment period, with detailed evaluation of breathing and vascular outcomes.

CONDITIONS

Brief 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 between 55 and 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 Fontaine classification)
  • 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 behavior
  • Cognitive impairment preventing participation in exercises

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive either inspiratory muscle training using The BREATHER device combined with aerobic exercise and pursed lip breathing, or aerobic exercise and pursed lip breathing with usual pharmacological treatment.

3 sessions per week

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

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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