Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803002938149 Date of Approval: 02/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diaphragmatic thickness response in relation to inspiratory and expiratory muscles training in adults
Official scientific title Diaphragmatic thickness response in relation to inspiratory and expiratory muscles training in adults
Brief summary describing the background and objectives of the trial This study was tried to conduct more easy physiotherapy intervention that may lead to strength the respiratory muscle and that will improve the lung compliance and diaphragmatic strength in adults also regular respiratory muscles training can help to preserve pulmonary function with aging and play a role in respiratory muscles training adaptations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory,Respiratory muscles weakness due to sedantry life
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 15/01/2018
Actual Last follow-up date 15/01/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 37
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
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 coin tossing Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group green powerlung device (trainer) 3 times per week for 6 weeks 10 minutes PowerLung is the only machine in the world designed to specifically train all of the respiratory ¿ breathing ¿ muscles one breathe at a time. 19
Control Group breathing exercises 3 times per week for 6 weeks 15-20 minutes chest physiotherapy including (diaphragmatic breathing, belt breathing, and localized breathing) 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult subjects of both sexes (men-women) 2. Their age were ranged from 20 to 30 years old. 3. Low to moderate physically active subjects according to international physical activity questionnaire (IPAQ). 4. Within normal average of BMI(18:25 Kg/m²) 5. Nonsmoker subjects. 1- Those with any chest diseases as ( COPD ( chronic obstructive pulmonary diseases), RLD (restrictive lung diseases), asthma and Active hemoptysis). 2- Presence of malignant disease. 3- Patients with acute infection. 4- Inability to comply and cooperate with study procedures. 5- Hemodynamic instability. 6- Recent facial, oral or Skull surgery or trauma within the skull. 7- Those with any musculoskeletal abnormalities as kyphosis, scoliosis and kyphoscoliosis 8- Those with cardiovascular diseases as mitral stenosis 20 Year(s) 30 Year(s) Both
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 28/02/2016 research ethical committee, faculty of physical therapy , cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzaiat st.Ben Elsaryat- El Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome diaphragmatic thickness and excursion after finishing the training
Secondary Outcome 2. Ventilatory measurement and Borg scale after finishing the training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy,Cairo university 7 Ahmed Elzaiat st.Ben Elsaryat- El Dokki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Gehad Ali Amer Abn Elaas 6 october Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university universty street Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Mohamed Ezz Eldin 6 october -Aoul el fyoum st Giza Egypt
Nesreen Ghareeb Mohamed Elnahas 65 Mohammed Ragaay extended from Elamal outostird street cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hala Ezz eldin mh10_2@yahoo.com 01006626043 6 october ,Aoul elfyom st
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Hala Ezz Eldin mh10_2@yahoo.com 01006626043 6 october ,Aoul elfyom st
City Postal code Country Position/Affiliation
giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Nesreen Elnahas nesreen_2512@yahoo.com 01002227242 65 Mohammed Ragaay extended from Elamal outostird street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information