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.: PACTR202006717277937 Date of Approval: 10/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Interferential Therapy on SARS-CoV-2. COVID-19
Official scientific title Efficacy of Interferential Therapy on Selected Cardiopulmonary Parameters of Asthmatic Patients with Post COVID-9 Exposure
Brief summary describing the background and objectives of the trial 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). Recent study by Aweto et al, (2015) demonstrated the efficacy of Interferential current in the management of bronchial asthma, Jackson et al (2015) highlighted poor asthma control as a risk factor for virus induced exacerbation in asthma while Sebastian and Johnston (2020) based on existing literature, identified the relationship between SARS-CoV-2 and asthma exacerbation while emphasizing the importance of asthma control as a measure of preventing respiratory complications that may arise from the viral exposure. Based on Sebastine and Johnston’s theory, this study was designed to investigate the efficacy of a non-invasive modality on the cardiopulmonary parameters, asthma control and quality of life of asthmatic patients recently exposed to COVID19.
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 01/10/2020
Actual trial start date
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Will be available upon publication
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IFT WITH SABA IN 45 DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION The patient will be in in 45° long sitting after the administration of 400mcg of SABA delivered in metered doses via a spacer. Using a 4,000 Hz base current, interferential current range will be set from 10 to 150 Hz and initially applied for 10 minutes, being careful to monitor the patient’s condition during the treatment period (Aweto et al, 2015). If the patient presents any sign of distress during the course of treatment, the current will be turned off. So long as the subject experiences no distress with IFC application, the treatment period will be increased by two minutes, with each application up to a total application time of 20 minutes 6
Experimental Group IFT WITH SABA IN 9O DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION The patient will be in in 90° long sitting after the administration of 400mcg of SABA delivered in metered doses via a spacer. Using a 4,000 Hz base current, interferential current range will be set from 10 to 150 Hz and initially applied for 10 minutes, being careful to monitor the patient’s condition during the treatment period (Aweto et al, 2015). If the patient presents any sign of distress during the course of treatment, the current will be turned off. So long as the subject experiences no distress with IFC application, the treatment period will be increased by two minutes, with each application up to a total application time of 20 minutes 6
Experimental Group IFT WITH SABA AND STEROIDS IN 45 DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION The patient will be in in 45° long sitting after the administration of 400mcg of SABA and corticosteroid delivered in metered doses via a spacer. Using a 4,000 Hz base current, interferential current range will be set from 10 to 150 Hz and initially applied for 10 minutes, being careful to monitor the patient’s condition during the treatment period (Aweto et al, 2015). If the patient presents any sign of distress during the course of treatment, the current will be turned off. So long as the subject experiences no distress with IFC application, the treatment period will be increased by two minutes, with each application up to a total application time of 20 minutes 6
Experimental Group IFT WITH SABA AND STEROIDS IN 90 DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION The patient will be in in 90° long sitting after the administration of 400mcg of SABA and corticosteroid delivered in metered doses via a spacer. Using a 4,000 Hz base current, interferential current range will be set from 10 to 150 Hz and initially applied for 10 minutes, being careful to monitor the patient’s condition during the treatment period (Aweto et al, 2015). If the patient presents any sign of distress during the course of treatment, the current will be turned off. So long as the subject experiences no distress with IFC application, the treatment period will be increased by two minutes, with each application up to a total application time of 20 minutes 6
Control Group IFT WITH SABA IN 45 DEGREES LONG SITTING POSITION 3 TIMES A WEEK 20 MINUTES PER SESSION They will be placed in 45° degrees long sitting and allowed to use 400ug of SABA delivered in metered doses via a spacer. They will be asked to maintain their respective positions for a period of 20 minutes. In the event that the subject is experiencing respiratory difficulty, the procedure will be discontinued. Musculoskeletal assessment will be conducted before and after the procedure. 6 Placebo
Control Group IFT WITH SABA AND STEROIDS IN 45 DEGREES LONG SITTING. 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION They will be placed in 45° degrees long sitting and allowed to use 400ug of SABA and corticosteroids delivered in metered doses via a spacer. They will be asked to maintain their respective positions for a period of 20 minutes. In the event that the subject is experiencing respiratory difficulty, the procedure will be discontinued. Musculoskeletal assessment will be conducted before and after the procedure. 6 Placebo
Control Group IFT WITH SABA IN 90 DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION They will be placed in 90° degrees long sitting and allowed to use 400ug of SABA delivered in metered doses via a spacer. They will be asked to maintain their respective positions for a period of 20 minutes. In the event that the subject is experiencing respiratory difficulty, the procedure will be discontinued. Musculoskeletal assessment will be conducted before and after the procedure. 6 Placebo
Control Group IFT WITH SABA AND STEROIDS IN 90 DEGREES LONG SITTING POSITION 3 TIMES A WEEK FOR 12 WEEKS 20 MINUTES PER SESSION They will be placed in 90° degrees long sitting and allowed to use 400ug of SABA and corticosteroid delivered in metered doses via a spacer. They will be asked to maintain their respective positions for a period of 20 minutes. In the event that the subject is experiencing respiratory difficulty, the procedure will be discontinued. Musculoskeletal assessment will be conducted before and after the procedure. 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 ● Individuals exposed to SARS-CoV-2 virus ● Individuals that has been isolated at the NCDC accredited centre ● 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,Aged: 65+ Year(s),Child: 6 Year-12 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
No 31/07/2020 THE NATIONAL HEALTH RESEARCH ETHICS COMMITTEE OF NIGERIA
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 9002112 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PULMONARY FUNCTION TEST PRE AND POST INTERVENTION
Secondary Outcome ASTHMA CONTROL TEST, ASTHMA QUALITY OF LIFE EVERY 2 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nigerian Centre for Disease Control 67 Murtala Mohammed Way, Yaba, Lagos, Nigeria. LAGOS 100213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Awolola Eniola Oladejo 1 Ojelabi Awolola Street, Onike-Yaba,Lagos Lagos 100213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AWOLOLA ENIOLA OLADEJO 1 Ojelabi Awolola Street, Onike-Yaba,Lagos LAGOS 100213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Sonill Sooknunan Maharaj Varsity drive, Westville Kwazulu Natal 4000 South Africa
Dr Bashir Kaka Varsity Drive, Westville Kwazulu Natal 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 Chief Physiotherapist
Role Name Email Phone Street address
Public Enquiries Sonill Maharaj maharajss@ukzn.ac.za +27834611413 varsity drive, westville
City Postal code Country Position/Affiliation
Kwazulu Natal 4000 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Bashir Kaka maharajss@ukzn.ac.za +2348056333106 varsity drive, westville
City Postal code Country Position/Affiliation
Kwazulu Natal 4000 South Africa Research partner
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data are all the informations that will be obtained from participants in the course of this study. The components of IPD for this study are the pulmonary variables, asthma control test, asthma quality of life questionnaire. 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, transferred and stored 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 researcher will have access to the records.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be available upon commencement of the study No
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