Using a Breather Device to Help COPD Patients with Leg Pain
Effect of Breather on Ventilatory and Vascular Function in Chronic Obstructive Pulmonary Disease Patients With Intermittent Claudication.
This study is testing if a special breathing device can help men with COPD and leg pain breathe better and exercise more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 60 Years |
| Sex | Male |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Dokki) |
| Trial ID | NCT06529185 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a breather device on both ventilatory and vascular functions in patients with Chronic Obstructive Pulmonary Disease (COPD) who also experience intermittent claudication. The intervention involves using an inspiratory muscle trainer to enhance muscle strength and endurance, reduce dyspnea, and improve exercise tolerance. The study will include sixty male patients aged 55-60 with specific inclusion criteria related to their COPD and leg pain. Participants will be monitored for improvements in their condition as a result of using the breather device.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 55-60 with grade I or II COPD and a history of intermittent claudication.
Not a fit: Patients with cardiovascular insufficiency, recent myocardial infarction, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and exercise capacity for COPD patients suffering from intermittent claudication.
How similar studies have performed: While there is emerging research on the benefits of inspiratory muscle training in COPD, this specific approach targeting both ventilatory and vascular function in the context of intermittent claudication is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dokki
- Faculty of Physical Therapy — Dokki, Egypt (Recruiting)
Study contacts
- Principal investigator: reem M farahat, student — Cairo University
- Study coordinator: Reem M Farahat, student
- Email: Reemfarahat42@gmail.com
- Phone: +201050770870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.