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.: PACTR202005807526130 Date of Approval: 12/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of non pharmacological agent in the management of Asthma
Official scientific title Comparative Efficacy of Interferential Therapy, Bronchodilators and Body Positioning on Airway Reversibility, Asthma Control and Quality of Life of Patients with Bronchial Asthma
Brief summary describing the background and objectives of the trial World-wide, approximately 300 million people are affected with bronchial asthma (Masoli, 2004). It has been observed to be more prevalent in developed countries with higher rates seen in Australia, UK, and New Zealand (Masoli, 2004). The prevalence of asthma ranges from 7% to 18% in Nigeria population (Ibe and Ele, 2002; Masoli, 2004; Erhabor et al, 2006; Desalu et al, 2009). Interferential therapy (IFT) is the application of two medium frequency currents to the skin in such a way that they "interfere" with each other to produce a "beat" frequency (Wendy, 1999). This beat frequency is the difference between the medium frequency currents; the body recognize it as the required low frequency current. Different systems can be stimulated and activated by using specific frequencies and frequency ranges. Interferential therapy induces expectoration by making sputum on the surface of the bronchi mobile, IFT reduces shoulder stiffness, muscular fatigue and myalgia in the chest and upper back regions (Shuto et al, 1986). For many years, the effectiveness of asthma medications has been assessed by measuring its impact on conventional clinical outcomes such as expiratory flow rates, symptoms, the need for other medications and airway responsiveness (Juniper et al, 2004). This is very important but none of them tells us whether the patients are actually able to function better in their day-to-day life (Juniper et al, 1993). This study is therefore designed to investigate the efficacy of a non invasive modality administered in 2 different fundamental body positions and its relationship with bronchodilators on Asthma control, Quality of life and Airway reversibility of patients with bronchial asthma over a period of 3 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 Treatment: Other
Anticipated trial start date 22/06/2020
Actual trial start date
Anticipated date of last follow up 21/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Not available yet
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 Simple randomization using a randomization table from a statistics book Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interferential Therapy and short acting bronchodilator at 45 degrees long sitting 3 times a week for 12 weeks 20 minutes Interferential treatment and short acting bronchodilator administered in 45° long sitting 6
Experimental Group Interferential Therapy and short acting bronchodilator at 90 degrees long sitting 3 times a week for 12 weeks 20 minutes Interferential Therapy and short acting bronchodilator administered at 90° long sitting 6
Experimental Group Interferential Therapy short acting bronchodilator inhaled corticosteroid at 45 degrees long sitting 3 times a week for 12 weeks 20 minutes Interferential Therapy combined with short acting bronchodilator and inhaled corticosteroid at 45 degrees long sitting 6
Experimental Group Interferential Therapy short acting bronchodilator inhaled corticosteroid at 90 degrees 3 times a week for 12 weeks 20 minutes Interferential Therapy combined with short acting bronchodilator and inhaled corticosteroid at 90 degrees long sitting 6
Control Group Musculoskeletal scanning short acting bronchodilator at 45 degrees 3 times a week for 12 weeks 20 minutes Musculoskeletal scanning, education on asthma, pulmonary function test , short acting bronchodilator at 45° 6 Placebo
Control Group Musculoskeletal scanning short acting bronchodilator at 90 degrees 3 times a week for 12 weeks 20 minutes Musculoskeletal scanning, education on asthma, Pulmonary function Test, short acting bronchodilator at 90 degrees 6 Placebo
Control Group Musculoskeletal scanning short acting bronchodilator and corticosteroids at 45 degrees 3 times per week for 12 weeks 20 minutes Musculoskeletal scanning, education and pulmonary function Test, short acting bronchodilator and corticosteroids at 45 degrees 6 Placebo
Control Group Musculoskeletal scanning short acting bronchodilator and corticosteroids at 90 degrees 3 times per week for 12 weeks 20 minutes Musculoskeletal scanning, education on asthma, pulmonary function test, short acting bronchodilator and corticosteroids at 90 degrees 6 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals above the Age of 10 years Individuals with bronchial asthma attending respiratory clinic of Lagos State University Teaching Hospital will participate in the study. Those on cardiac pacemaker Those with cardiac conditions Those with other types of COPD other than bronchial asthma Those on supplemental oxygen therapy Those with psychological disorders Those with status asthmaticus Those that are under 10 years Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 65 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 10/02/2021 Biomedics and research ethics committee University of KwazuluNatal
Ethics Committee Address
Street address City Postal code Country
Westville Campus, Govan Mbeki Building, Private Bag X 54001, Durban, 4000, KwaZulu-Natal, South Africa KwazuluNatal 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FEV1 At every appointment, pre and post intervention
Primary Outcome FVC At every appointment, pre and post intervention
Primary Outcome FEV1/FVC At every appointment, pre and post intervention
Primary Outcome PEFR At every appointment, pre and post intervention
Secondary Outcome Asthma Control Test Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.
Secondary Outcome Asthma Quality of Life Questionnaire Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University teaching Hospital Ikeja Lagos. 1-3 Oba Akinjobi way, Ikeja, Lagos Lagos 100271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Awolola Eniola Oladejo 1 Ojelabi Awolola Street, Onike-Yaba Lagos 100213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lagos State University Teaching Hospital Ikeja Lagos 1-3 Oba Akinjobi way, Ikeja, Lagos Lagos 100271 Nigeria Study leave
COLLABORATORS
Name Street address City Postal code Country
Professor Sonill Sooknunan Maharaj Varsity drive, estville Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eniola Awolola ptoladejo@physiomedicare.org +2348056333106 1 Ojelabi Awolola Street, Onike-Yaba,Lagos
City Postal code Country Position/Affiliation
Lagos 100213 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Abdulsalam Yakasai abdulpeace1@gmail.com +2348060840806 Varsity drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa Research assistant
Role Name Email Phone Street address
Scientific Enquiries Sonill Maharaj Maharajss@ukzn.ac.za +2348056333106 Varsity drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data are all the informations that will obtained from participants in the course of this study. The components of IPD for this study are the Cardiopulmonary variables and the quality life tools. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All data will be kept and shared for a period of 5 years. The records will be destroyed after 5 years Data obtained will be kept under lock and key, transfered and stored electronically in excel sheet format thereafter the records will be password protected on a computer domicile at the department of Physiotherapy, college of Health sciences, University of Kwazulu-Natal. Only the researchers will have access to it
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be available upon commencement of the study. Yes 13/04/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/04/2022 Result - 22/10/2022 Result - 22/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://doi.org/10.4081/hls.2022.10251
Changes to trial information