Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05618847
Other study ID # REC&Mishal Sabir
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date February 2023

Study information

Verified date November 2022
Source Riphah International University
Contact Imran amjad, PHD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We are conducting this study to check the effects of active cycle of breathing technique with or without acapella on airway clearance, dyspnea and pulmonary function test in COPD patients. Study design will be randomized controlled trial. Research will be conducted at Aziz Bhatti Shaheed Teaching Hospital and National Hospital Gujrat. Written informed consent will be obtained. Patients will be allocated randomly in two groups. Subjects will meet the predetermined inclusion and exclusion criteria. Questionnaire used as subjective measurements of dyspnea and sputum will be given and pulmonary function test values will be obtained prior to any intervention. One group will receive active cycle of breathing technique and the other group will receive active cycle of breathing technique with acapella device. Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets. At the end of 4 weeks treatment session, pulmonary function test values will be monitored and questionnaire will be obtained for dyspnea and sputum. Data will be analyzed on SPSS 25


Description:

Chronic Obstructive Pulmonary Disease (COPD) is a non-communicable progressive and non-curable disease, characterized by persistent respiratory symptoms and airflow limitation. It is potentially fatal and it is the fourth cause of death in the world. Active Cycle of Breathing Techniques can be used to mobilize and clear excess pulmonary secretions and to generally improve lung function Loosen and clear secretions from the lungs. Three main phases of Active Cycle of Breathing Techniques are Breathing Control, Deep Breathing Exercises or Thoracic Expansion Exercises and Huffing or Forced Expiratory Technique. Acapella is a small hand held device for airway clearance. It has both resistive and vibratory features, which help to loosen and clear secretions from chest. This causes the vibration and resistance to the airflow which is then transmitted to the lungs. The resistance to the airflow will help to keep the airways open to get air behind the sputum and help it move upwards. The vibrations will help to loosen secretions from airways and move them up more easily for effective chest clearance. We are conducting this study to check the effects of active cycle of breathing technique with or without acapella on airway clearance, dyspnea and pulmonary function test in COPD patients. Study design will be randomized controlled trial. Research will be conducted at Aziz Bhatti Shaheed Teaching Hospital and National Hospital Gujrat. Written informed consent will be obtained. Patients will be allocated randomly in two groups. Subjects will meet the predetermined inclusion and exclusion criteria. Questionnaire used as subjective measurements of dyspnea and sputum will be given and pulmonary function test values will be obtained prior to any intervention. One group will receive active cycle of breathing technique and the other group will receive active cycle of breathing technique with acapella device. Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets. At the end of 4 weeks treatment session, pulmonary function test values will be monitored and questionnaire will be obtained for dyspnea and sputum. Data will be analyzed on SPSS 25


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date February 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - • Age:45-75 - Both genders - Mentally stable - Diagnosed patients of COPD Exclusion Criteria: - • Any neurological condition - Arrythmias - Heart failure - Previous heart or lung surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acapella,ACBTS
Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets
Other:
ACBTs
Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets

Locations

Country Name City State
Pakistan Aziz bhatti shaheed teaching hospital Gujrat Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sputum diary The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms) 4 weeks
Primary Dyspnea-MDP scale The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses 4 weeks
Primary Pulmonary function test Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. They provide important information relating to the large and small airways, the pulmonary parenchyma and the size and integrity of the pulmonary capillary bed 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy