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Recruiting NCT06529185

Effect of Breather in COPD Patients With Intermittent Claudication

No phase Interventional COPD PAD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The BREATHER, pharmacological treatment.
Who it may be relevant to
Registry conditions: COPD, PAD. Basic parameters: 50 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Device The BREATHER
    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
  • Drug pharmacological treatment
    patient will receive the usually pharmacological treatment.

Primary outcome measures

  • Ventilatory function: by spirometry test [Time frame: 4 weeks]
  • Vascular function: by doppler ultrasound [Time frame: 4 weeks]
Secondary outcome measures (2)
  • Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS) [Time frame: 4 weeks]
  • Treadmill exercise testing [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy — Dokki

Publications

  • Beaumont M, Forget P, Couturaud F, Reychler G. Effects of inspiratory muscle training in COPD patients: A systematic review and meta-analysis. Clin Respir J. 2018 Jul;12(7):2178-2188. doi: 10.1111/crj.12905. Epub 2018 May 23. PMID 29665262
  • Pinto B, Correia MV, Paredes H, Silva I. Detection of Intermittent Claudication from Smartphone Inertial Data in Community Walks Using Machine Learning Classifiers. Sensors (Basel). 2023 Feb 1;23(3):1581. doi: 10.3390/s23031581. PMID 36772621
  • Terzikhan N, Lahousse L, Verhamme KMC, Franco OH, Ikram AM, Stricker BH, Brusselle GG. COPD is associated with an increased risk of peripheral artery disease and mortality. ERJ Open Res. 2018 Dec 21;4(4):00086-2018. doi: 10.1183/23120541.00086-2018. eCollection 2018 Oct. PMID 30588480
  • Elsayed MM, Farahat RM, Serry ZH, Almeldin AI. Inspiratory Muscle Training and Aerobic Exercise Affect Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication: A Randomized Controlled Trial. Physiother Res Int. 2026 Jan;31(1):e70130. doi: 10.1002/pri.70130. PMID 41287032

Identifiers

NCT: NCT06529185 · Breather on COPD with IC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗