Clinical trial NCT06529185: Effect of Breather in COPD Patients with Intermittent Claudication
Official title: Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients with Intermittent Claudication.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
PAD
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Ventilatory function: by spirometry test
timeFrame: 4 weeks
measure: Vascular function: by doppler ultrasound
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)
timeFrame: 4 weeks
measure: Treadmill exercise testing
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Zahra M Serry, Assist.Prof
role: STUDY_DIRECTOR
affiliation: Cairo University
name: MARWA M ELSAYED, Assist.Prof
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Amira I Almeldin, Assist.Prof
role: STUDY_DIRECTOR
affiliation: Cairo University
name: reem M farahat, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.