Effect of Breather in COPD Patients with Intermittent Claudication

NCT06529185 | Recruiting

• 1 other identifier: Breather on COPD with IC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; PAD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  4 weeks

• Treadmill exercise testing

  4 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: experimental group

treatment group

pharmacological treatment DRUG

patient will receive the usually pharmacological treatment.

Also known as: control group

control group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Dokki, Egypt

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Drug Therapy; Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  STUDY DIRECTOR

• reem M farahat, student

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem M Farahat, student

CONTACT

+201050770870; Reemfarahat42@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: July 30, 2024
• Primary Completion: December 20, 2024
• Study Completion: February 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)