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NCT Number: NCT06529185

Effect of Breather in COPD Patients With Intermittent Claudication

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

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Key information

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Dokki, Egypt

Location status: Recruiting

Location contact

Reem Farahat, master

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: experimental group

Pharmacological treatment

Drug

patient will receive the usually pharmacological treatment.

Other names: control group

Primary outcomes

  1. Ventilatory function: by spirometry test

    Time frame: 4 weeks

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

  2. Vascular function: by doppler ultrasound

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)

    Time frame: 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.

  2. Treadmill exercise testing

    Time frame: 4 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Reem M Farahat, student

CONTACT

[email protected]

+201050770870

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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