Penang hospital
George Town, Pulau Pinang, 10990, Malaysia
NCT Number: NCT01480882
A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage.
The aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or Chronic obstructive Pulmonary disease (COPD).
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
George Town, Pulau Pinang, 10990, Malaysia
This study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional chest percussion will be applied for a duration of 15 minutes.
Other names: Manual percussion
Mechanical chest percussion will be delivered by a device for 15 minutes.
Other names: LEGA
Time frame: 6 days
The patients will be instructed to cough out the sputum into a preweighed container during the 15 minutes of the procedure(Manual or mechanical percussion)and 5 minutes after the procedure.Container will be weighed to get the wet weight of the sputum then will be dried in a laboratory oven at 60degree c for 48 hours and weighed again to get the dry weight of the sputum
Time frame: 15 minutes after completion of the procedure compared to baseline
Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted)
Time frame: 15 minutes after completion of treatment compared to baseline
Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.
Time frame: After completing 6 days of participation in the study
Patients will be participating in the study for 6 days. On the 6th day after completion of treatment they will be required to answer a simple questionnaire to find out if they prefer one procedure over the other and why.
Penang Hospital, Malaysia
Other Gov
"A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor "LEGA" Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD
Acronym: LEGA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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