High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Post(SARS-CoV-2)

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591781
Collaborator
(none)
60
1
2
2
29.9

Study Details

Study Description

Brief Summary

COPD causes an acute deterioration of respiratory symptoms, particularly increased breathlessness and cough, and increased sputum volume and/or purulence. Worsening airflow limitation is associated with an increasing prevalence of exacerbations and risk of death. These exacerbations can range from self-limited diseases to episodes of florid respiratory failure requiring mechanical ventilation .Hospitalization for COPD patients post COVID is associated with poor prognosis with increased risk of death. Hence techniques of efficient clearance of peripheral airways may reduce airway occlusion by excess mucus and inflammatory cells, improving lung function, exercise capacity and reducing exacerbation frequency.

Condition or Disease Intervention/Treatment Phase
  • Device: high frequency chest wall oscillation with vest system
  • Device: Lung flute (OPEP)
N/A

Detailed Description

Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application. Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes. Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 2 times per week twice a day for three successive weeks and the total duration of each session was 10-15 minutes

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Postcovid
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vest Airway Clearance System

Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes

Device: high frequency chest wall oscillation with vest system
Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application.

Active Comparator: Lung flute (OPEP)

Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day

Device: Lung flute (OPEP)
. Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day for three successive weeks

Outcome Measures

Primary Outcome Measures

  1. Forced vital capacity (FVC) [Forced vital capacity (FVC)will be measured at baseline, and after three weeks.]

    FVC is the amount of air that can be forcibly exhaled from lungs after deepest inspiration, it's measured by spirometry

  2. Forced expiratory volume in one second (FEV1) [FEV1 will be measured at baseline, and after three weeks.]

    FEV1 is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation

  3. FEV1/FVC ratio [FEV1/FVC ratio will be measured at baseline, and after three weeks.]

    The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function

  4. The forced mid-expiratory flow (FEF25-75%) [(FEF25-75%) will be measured at baseline, and after three weeks.]

    (FEF25-75) measures the average flow rates of medium-to-small airways during the forced vital capacity (FVC).it' is a potentially sensitive marker of obstructive peripheral airflow

Secondary Outcome Measures

  1. Six-minute walk test [6min walk test will be measured at baseline, and after three weeks.]

    Six-minute walk test was carried out before and after interventions to determine the patient functional capacity

  2. COPD assessment test (CAT [COPD assessment test (CAT)will be measured at baseline, and after three weeks.]

    is a validated, short (8-item) and simple patient completed questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients aged 40-60 years old

  • All patients were recovered from COVID not more than 3 months

  • All patients were diagnosed as COPD for at least two years ago.

  • All patients had irreversible/ partially reversible obstruction of airflow.

  • COPD patients had a post-bronchodilator, FEV1/FVC% < 70%. They had an increase in FEV1< 200 ml, or < 12% of baseline value 20 minutes after 2 puffs of inhaled salbutamol (100 µg) given via a metered-dose inhaler.

Exclusion Criteria:
  • Presence of malignant disease.

  • Patients with acute infection.

  • History of osteoporosis, significant gastro-oesophageal reflux, hiatus hernia.

  • Recent acute cardiac event (6 weeks) or congestive cardiac failure.

  • Any significant musculoskeletal disorders.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo Egypt 11432

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaa Mohamed El-Moatasem Mohamed, lecturer of physical therapy, Cairo University
ClinicalTrials.gov Identifier:
NCT05591781
Other Study ID Numbers:
  • P.T.REC/012/003822
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2022