Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003091341 Date of Approval: 14/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Respiratory Muscle Training on Ventilatory Functions of Chronic Obstructive Pulmonary Disease Patinets
Official scientific title Effect of Respiratory Muscle Training on Ventilatory Functions of Chronic Obstructive Pulmonary Disease Patinets
Brief summary describing the background and objectives of the trial This work was designed to assess the effect of respiratory muscle training on ventilatory functions of Chronic Obstructive Pulmonary Disease Patients . . with the hypothesis that there might be no effect of using Respiratory muscle training on ventilatory functions of Chronic Obstructive Pulmonary Disease patients . Sixty patients with spirometric evidence of significant chronic airflow limitation with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) of both sexes were enrolled for this study. They were chosen from outpatient clinic Kasr El-ainy Hospital and agreed to participate in the study. They signed a consent form; they were diagnosed and referred by chest physician. The patients was randomly divided into two groups equal in number. Group A (30 patients was received powerlung device plus conventional chest physiotherapy ) in addition to medical treatment. Group B (30 patients was received conventional chest physiotherapy) in addition to medical treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied CHRONIC OBSTRUCTIVE PULMONARY DISEASE,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/10/2017
Actual trial start date 10/10/2017
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date 08/05/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/001573 faculty of physical therapy cairo university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A 3 month 30 patients was received powerlung device plus conventional chest physiotherapy ) in addition to medical treatment. 30
Experimental Group group B 3 month 30 patients was received conventional chest physiotherapy) in addition to medical treatment 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ They suffer from 5-year history of chronic obstructive lung disease. ¿ Their BMI is from 25 to 34.9 kg/m² ¿ Their age range from 40 ¿ 60 years old of both sexes. ¿ They are medically controlled. ¿ The patients fulfilled the criteria for COPD: the presence of a post bronchodilator FEV1 > 80% predicated together with an FEV1/FVC <0.70 confirm the presence of airflow limitation that is not fully reversible .( Global Initiative for Chronic Obstructive Lung Disease, 2016) ¿ GOLD criteria were also followed for staging COPD severity into mild (FEV1>80%, stage I), moderate (FEV1 between 50% and 80%) stage II and Severe (30% ¿ FEV1 < 50% predicted) stage III(Global Initiative for Chronic Obstructive Lung Disease, 2016). ¿ Patients with recent COPD exacerbation ¿ Unstable angina ¿ Respiratory tract infection within 1 month of the start of the study ¿ Myocardial infarction ¿ Angioplasty ¿ Heart surgery in the previous 3 months ¿ Basal blood pressure > 180/100 mmHg, resting pulse rate > 120 bpm ¿ Body mass index (BMI) > 35 kg/m2 ¿ Chronic renal impairments ¿ Epistaxis . ¿ Active Haemoptysis. ¿ Recent facial, oral, or skull surgery or trauma. 40 Year(s) 60 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2017 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza cairo +2 02 37617692 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FEV1 , FEVI/FVC ratio pre and post intervention 3 month
Secondary Outcome FVC, PEFR, PIFR , MVV ,Maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax) pre and post intervention 3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza cairo +2 02 37617692 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
non
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor non Hospital
Primary Sponsor non Hospital
Primary Sponsor non non non Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Non
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator elhadidy hagar ha_am_hadidy@hotmail.co 01007453552 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
cairo 0098 Egypt external
Role Name Email Phone Street address
Public Enquiries elhadidy hagar hagarhadidy2016@gmail.com 01007453552 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
cairo 0098 Egypt external
Role Name Email Phone Street address
Scientific Enquiries El-Refay Basant bassanthamdy@yahoo.com 01007453552 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
cairo 0098 Egypt external
Role Name Email Phone Street address
Scientific Enquiries elhadidy hagar hagarhadidy2016@gmail.com 01007453552 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
cairo 0098 Egypt external
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information