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.: PACTR201604001538133 Date of Approval: 21/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IMPACT OF SOFT TISSUE MANIPULATION VERSUS CHEST PHYSIOTHERAPY ON DIAPHRAGMATIC EXCURSION IN ASTHMATIC PATIENTS
Official scientific title IMPACT OF SOFT TISSUE MANIPULATION VERSUS CHEST PHYSIOTHERAPY ON DIAPHRAGMATIC EXCURSION IN ASTHMATIC PATIENTS
Brief summary describing the background and objectives of the trial Sixty persons of both sexes suffered from mild to moderate asthma will participate in this study; they will be chosen from chest clinic -Radio and Television Union. Subjects will be randomly assigned into two groups equal in number, A and B; each of them consisted of 30 participants. Group A: enrolled into soft tissue manipulation, while, Group B: traditional physiotherapy program (pursed lip breathing exercise, Diaphragmatic Breathing exercise) for three months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/05/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 01/05/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
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 PERMUTED BLOCK RANDOMISATION RANDOM NUMBER GENERATOR Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SPINAL MANIPULATION ONCE WEAKLY THREE MONTHS Manipulation for C0-C1 AND Upper dorsal spine at the level of T3-4 AND MUSCLE ENERGY TECHNIQUE 30
Experimental Group BREATHING EXERCISE THREE TIME WEAKLY THREE MONTHS Pursed lip breathing AND Diaphragmatic breathing exercise 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects meeting the following criteria will be enrolled in this study: 1. Their age ranges from 35 to 45years 2. All of them have mild to moderate asthma (60 %< FEV1<90%). (Gene,2004) 3- They experienced the symptoms at least 12 months ago 4. All subjects will be under medical control, receiving their prescribed medications. - Any other chest diseases - Major cardiovascular problems. - Recent heart surgery. - Uncontrolled hypertension. - Uncontrolled diabetes mellitus. - Subject unwilling to participate in the study or unable to cooperate. -osteoporoses - Major neurological problems; stroke, epileptic patients. - History of fractures of vertebrae - History of cerebro-vascular accident. - Recent surgery 25 Year(s) 45 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 08/03/2016 physical therapy faculty cairo university
Ethics Committee Address
Street address City Postal code Country
ben el sarayat el -behoos el doky cairo 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Asthma control questionnaire degree of asthma (mild- moderate - severe)
Secondary Outcome Forced Vital Capacity (FVC), Forced Expired Volume in one second (FEV1), the ratio of FEV1 and FVC (FEV1%), Peak expiratory flow (PEF measured by spirometer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
chest clinic MASPIRO CAIRO 11511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 3 el hossiny street maddi CAIRO 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mostafa mohamed shams 3 el hossiny street maddi CAIRO 11728 Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
mostafa mohamed shams 3 el hossiny street maddi CAIRO 11728 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mostafa shams mostafaosteostudent@yahoo.com 00201007288861 3 el hossiny street maadi
City Postal code Country Position/Affiliation
cairo 11728 Egypt senior
Role Name Email Phone Street address
Public Enquiries amr mostafa amryehia8152@gmail.com 00201159388770 19 makram ebid extension nasrcity
City Postal code Country Position/Affiliation
cairo 11759 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries EMAD MOHSEN emad_pt@outlook.com 01028799322 EL DOKY STREET
City Postal code Country Position/Affiliation
CAIRO 5473 Egypt PHYSICAL THERAPIST
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
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information