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.: PACTR201703002095224 Date of Approval: 12/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Respiratory muscle training in chronic obstructive pulmonary disease
Official scientific title Comparative study between two different respiratory training protocols in patients with chronic obstructive pulmonary disease
Brief summary describing the background and objectives of the trial to compare between the effect of inspiratory muscle training and expiratory muscle training in patients with COPD as regards respiratory muscle strength, functional capacity and arterial blood gases
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 with mild to moderate airways obstruction, medically stable with no recent exacerabations,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/03/2014
Actual trial start date 02/03/2014
Anticipated date of last follow up 04/05/2014
Actual Last follow-up date 11/05/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL not yet published
Secondary Ids Issuing authority/Trial register
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 by using sealed envelopes Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group expiratory muscle training threshold expiratory muscle trainer using the same intensity which ranged from 15% of maximal expiratory pressure and was upgraded to 60% at the end of the two months 8 weeks Expiratory muscle training group received resisted breathing exercises to expiratory muscles with threshold expiratory muscle trainer using the same intensity which ranged from 15% of maximal expiratory pressure and was upgraded to 60% at the end of the two months. The group also received sham or placebo inspiratory muscle training using inspiratory muscle trainer with a fixed low load of 7 cmH2O. 20 Placebo
Experimental Group inspiratory muscle training The resistance of the valve was adjusted to be 15% of MIP the beginning of the training program and was upgraded by 5-10% each session with weekly adjustment for the intensity 8 weeks Inspiratory muscle training group received training in the form of 6 sets and each set consisted of 5 deep breathes against the trainer which contains a stainless steel spring loaded valve which is a one ¿ way valve that offers resistance to the inspiratory muscles. Also this group received sham expiratory muscle training with a load of 7 CmH2O 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All of them were smoker with an index of less than 400 (mild to moderate degree). forced expiratory volume in the first second (FEV1) ¿ 50- 70% of the predicted value severe airflow obstruction (FEV1< 50% of the predicted, Chest infection in the previous 2 months chronic respiratory failure who may need supplemental O2, or had CO2 retention drugs such as corticosteroids or anabolic steroids with in the previous 3 months which could affect exercise capacity cardiac disease, neurological or musculoskeletal disorders, pulmonary hypertension and mental disorders that could affect cooperation 57 Year(s) 63 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 20/01/2013 Imbaba National Institute for Allergy and Chest Diseases Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Imbaba Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome respiratory muscle strength one week after the end of training program
Secondary Outcome arterial blood gases one week after the end of training program
Secondary Outcome functional capacity in the form of walking test one week after the training program
Primary Outcome respiratory muscle strength was measured using spirometry to measure maximal inspiratory pressure and maximal expiratory pressure one week after the end of training program
Secondary Outcome arterial blood gases was measured using Gas analyzer (Sao2%,PaO2, PaCO2, HCO3, PH). one week after the end of training program
Secondary Outcome functional capacity in the form of six- minute walking test. The test was performed in a 30 ¿ m corridor to walk as fast as possible and patients were allowed to stop if they can not go on . Pulse oximetry was used during test, to stop the walking if their SpO2 dropped 4 % below the resting value or it became less than 90%. one week after the training program
Primary Outcome respiratory muscle strength was measured using spirometry to measure maximal inspiratory pressure and maximal expiratory pressure one week after the end of training program
Secondary Outcome arterial blood gases was measured using Gas analyzer (Sao2%,PaO2, PaCO2, HCO3, PH). one week after the end of training program
Secondary Outcome functional capacity in the form of six- minute walking test. The test was performed in a 30 ¿ m corridor to walk as fast as possible and patients were allowed to stop if they can not go on . Pulse oximetry was used during test, to stop the walking if their SpO2 dropped 4 % below the resting value or it became less than 90%. one week after the training program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Imbaba National Institute for Allergy and Chest Diseases, Giza, outpatient clinic Imbaba Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
pulmonary function testing lab and investigation lab at the institute for Imbaba National Institute for Allergy and Chest Diseases Imbaba Giza governorate 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Sherin H M Mehani Benisuef Elgadata, street no 18 Benisuef 62511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Yosri Mohammed Akl Giza governorate 12511 Egypt
Prof. Dr. Yosri Mohammed Akl Elmaneyl street Giza governorate 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
Role Name Email Phone Street address
Public Enquiries Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
Role Name Email Phone Street address
Scientific Enquiries Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
REPORTING
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Result URL Hyperlinks
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