Effect of Breather in COPD Patients with Intermittent Claudication

Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease 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.

Study Overview

• Status: Recruiting
• Conditions: COPD; PAD
• Intervention / Treatment: Device: The BREATHER; Drug: pharmacological treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem M Farahat, student; Phone Number: +201050770870; Email: Reemfarahat42@gmail.com

Study Locations

• Egypt
  • Dokki, Egypt
    • Recruiting
    • Faculty of Physical Therapy
    • Contact: Reem Farahat, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; This group include 30 patients with COPD and intermittent claudication. These patients can receive aerobic exercise (by applying treadmill exercise for 20 min) and inspiratory muscle training (by using The BREATHER device with Light/Medium resistance for 3-5 sets /session), for 4 weeks (3 sessions per week) and pursed lip breathing.	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; Other Names: experimental group
Active Comparator: control group; This group include 30 patients with COPD and intermittent claudication. These patients can receive pursed lip breathing and aerobic exercise (by applying treadmill exercise for 20 min) with the usually pharmacological treatment, for 4 weeks (3 sessions per week).	Drug: pharmacological treatment; patient will receive the usually pharmacological treatment.; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory function: by spirometry test	Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time.	4 weeks
Vascular function: by doppler ultrasound	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity assessment: by 5 repetitions sit to stand test (5R-STS)	(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.	4 weeks
Treadmill exercise testing	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).	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Zahra M Serry, Assist.Prof, Cairo university; Study Director: MARWA M ELSAYED, Assist.Prof, Cairo university; Study Director: Amira I Almeldin, Assist.Prof, Cairo university; Principal Investigator: reem M farahat, student, Cairo university

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: Breather on COPD with IC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No