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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408486728820 Date of Registration: 13/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Physiotherapist -Led Behavioural Change Therapy on Physical Activity and Clincal outcmes of indiviuals with Asthma in Kano, Nigeria: A Mixed Method
Official scientific title Effect of Physiotherapist -Led Behavioural Change Therapy on Physical Activity and Clincal outcmes of indiviuals with Asthma in Kano, Nigeria: A Mixed Method
Brief summary describing the background and objectives of the trial The burden of asthma is concerning as the prevalence of the disease has continued to rise due to growing urbanization and other factors such as indoor air pollution, especially in developing countries where copious domestic cooking are done with solid fuels (Guarnieri & Balmes, 2014; Rodriguez et al., 2019). Although higher prevalence rates of the disease are observed in resource-rich countries, many resource-poor nations are also significantly affected (Enilari & Sinha, 2019).Management of asthma can be achieved through the use of appropriate pharmacological and non-pharmacological interventions with good compliance levels. The pharmacological approach mainly involves the use of medications such as corticosteroids and short-acting β-agonists (SABA) (Patel & Shaw, 2015), whereas the non-pharmacological approach involves avoidance of environmental exposures , breathing techniques, smoking cessation and pulmonary rehabilitation (PR) (Bruurs, van der Giessen, & Moed, 2013; Zampogna, Zappa, Spanevello, & Visca, 2020). Generally, the goals of asthma management are to achieve optimal symptom control and minimize future risk of exacerbations and maintain normal activity levels (Program, 2007). Despite advancement in treatment techniques, asthma symptoms are often poorly controlled or remain uncontrolled (Larsson et al., 2020). objectives of the study 1. Determine the effect of 8- week Physiotherapy Led Behavioral Change Therapy in promoting physical activity and clinical outcomes among adults with asthma. 2. Ascertain the effect of 8-week usual care (control) on PA and selected clinical variables among adults with asthma. 3. To determine factors affecting intervention adherence following the 8-week physiotherapist lead BCT such as socio-cultural, psychological, and environmental factors that influence participants' adherence to the 8 week Physiotherapy Led Behavioral Change Therapy program.
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 Education /Training
Anticipated trial start date 20/08/2024
Actual trial start date 20/08/2024
Anticipated date of last follow up 30/10/2025
Actual Last follow-up date 30/10/2025
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 56
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Behavioural change Technique plus usual care Participants in this group will receive eight one-on-one face-to-face BCT programme led by a physiotherapist (the primary researcher), which will be held once per week, with each consultation lasting approximately 40 minutes. 8 weeks Participants will undergo a Behaviour change intervention aiming to enhance participation in Physical activity (PA) and reduce sedentary time. The program protocol will be adopted from Freitas et al, (2019) which was based on the trans theoretical model that identifies behavior change as a dynamic process that moves through stages and that underpins change through goal-setting, skill-development and self-control, Participants in this group will receive eight one-on-one face-to-face BCT programme led by a physiotherapist (the primary researcher), which will be held once per week, with each consultation lasting approximately 40 minutes. At the beginning of the intervention programme, the participants’ PA behavior level will be measured using a validated questionnaire developed by Ribeiro, Martins and Carvalho (2007). and also they will be given a physical activity monitor to wear 3 days prior to the BCT programme and throughout the BCT progmmme. During each session of the BCT, data from the activity monitor will be downloaded and reviewed. An individual action plan, tailored according to each participant's level of PA and behavior change stage will be established with realistic goals to encourage participants to increase time spent in PA. 22
Control Group Education plus usual care The education program will consist of two 90-min classes, to be held at the first and third week, which will be delivered by the primary researcher 2 weeks Participants allocated to the control group will receive usual care in addition to an educational program, which will be similar to that described by Freitas et al (2019, 2021). The education program will consist of two 90-min classes, to be held at the first and third week, which will be delivered by the primary researcher. The first session will address asthma education, which will include information about the pathophysiology of asthma, instructions on both medication and use of the peak flow meter, self-monitoring techniques, environmental control techniques and avoidance strategies. The second session will describe the current international PA recommendations as well as the importance and benefits of being physically active and maintaining a healthy lifestyle (Freitas et al., 2019, 2021). 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Male and female adults with asthma who are aged 18 years and above ii. A confirmed diagnosis of moderate to severe asthma by a physician and undergoing treatment by means of inhaled medications for at least 6 months iii. Ability to understand instruction in English or Hausa language. i. Patients who are not willing to participate or refuse to provide consent. ii. Patients with other co-existing chronic medical conditions (e.g., lung or oropharyngeal cancer by self-report or case folder ) iii. Current and active smokers as smoking habit has been shown to negatively affect lung function in smokers generally iv. Pregnant women v. Patients with prior history of thoracic surgery Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s) 18 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 12/04/2024 Health Research Ethics Committee Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Post office road, Kano Kano 3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical activity levels and Asthma control At baseline, 8 weeks and 3 months post intervention follow-up
Secondary Outcome Quality of life, Forced expiratory volume in first seconds, Forced Vital Capacity, self-efficacy, anxiety and depression At baseline, 8 weeks, 3 months post intervention follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammad Specialist Hospital Kano Kano 700271 Nigeria
Mohammad Abdullahi Wase Teaching Hospital Kano Kano 700271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano Gwarzo Road, Kano Kano 700241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano Gwarzo Road, Kano Kano 700241 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AISHA AHMAD AHMAD aaahmad.pth@buk.edu.ng +2348038738643 Gwarzo Road,Kano
City Postal code Country Position/Affiliation
Kano 700241 Nigeria Lecturer I Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Jibril Mohammed jmohammed.pth@buk.edu.ng 2347033537472 Gwarzo Road, Kano
City Postal code Country Position/Affiliation
Kano 700241 Nigeria Associate Proffessor Bayero University Kano
Role Name Email Phone Street address
Public Enquiries Aishat Shittu ashitu.pth@buk.edu.ng +2348036785233 Gwarzo Road, Kano
City Postal code Country Position/Affiliation
Kano 700241 Nigeria Senior Lecturer Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. The individual participant data will be available at the end of work 2. All of the individual participant data that will be collected during the trial after de-identification 3.No other document will be available aside from the aforementioned 4. Data will be available immediately following publication 5.The Data will be available to any one whom wishes to access it, 6.For any purpose 7.The data will be available indefinitely through a linked document Study Protocol RESULT WHEN READY FIRST JOURNAL PUBLICATION DATE
URL Results Available Results Summary Result Posting Date First Journal Publication Date
RESULT URL HYPERLINKS 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 06/06/2024 The reviewer mentioned that I should write the public title both with upper and lower case were necessary EFFECT OF PHYSIOTHERAPY LED BEHAVIOURAL CHANGE THERAPY ON PHYSICAL ACTIVITY AND CLINICAL OUTCOMES OF INDIVIDUALS WITH ASTHMA IN KANO STATE, NIGERIA: A MIXED METHOD STUDY Effect of Physiotherapist -Led Behavioural Change Therapy on Physical Activity and Clincal outcmes of indiviuals with Asthma in Kano, Nigeria: A Mixed Method
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 06/06/2024 The reviewer mentioned that I should write the public title both with upper and lower case were necessary EFFECT OF PHYSIOTHERAPY LED BEHAVIOURAL CHANGE THERAPY ON PHYSICAL ACTIVITY AND CLINICAL OUTCOMES OF INDIVIDUALS WITH ASTHMA IN KANO STATE, NIGERIA: A MIXED METHOD STUDY Effect of Physiotherapist -Led Behavioural Change Therapy on Physical Activity and Clincal outcmes of indiviuals with Asthma in Kano, Nigeria: A Mixed Method
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 19/04/2026 Recruitment commenced after approval was obtained 01 Jul 2024 02 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 21/04/2026 I did not start the study until after i obtained my trial approval later 02 Sep 2024 20 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 19/04/2026 Recruitment commenced after approval was obtained 01 Jul 2024 02 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/04/2026 I did not start the study until after I obtained my trial approval later 02 Sep 2024 20 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 19/04/2026 participants where not recruited at a time that is what made the follow-up duration longer 30 Mar 2025 30 Oct 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 19/04/2026 participants where not recruited at a time that is what made the follow-up duration longer 30 Mar 2025 30 Oct 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/04/2026 then I added 10 % attrition to get 44 participants but due to the fear of poor turn out i made the attrition rate to 40% looking at the economic situation 44 56
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/04/2026 it was an oversight, i did not update about the completion of the study Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 08/08/2024 The reviewer stated that the recruitment centers should be each in its own line Murtala Muhammad Specialist Hospital and Mohammad Abdullahi Wase Teaching Hospital, Kano, Kano, 700271, Nigeria Murtala Muhammad Specialist Hospital , Kano, Kano, 700271, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 08/08/2024 The reviewers stated that each recruitment area should be in its own line Mohammad Abdullahi Wase Teaching Hospital, Kano, Kano, 700271, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2024 The ethical approval letter was taken back to the ethics committee for stamping which was not done before TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smoh.kano2019@gmail.com, 29388_29538_4737.pdf TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smoh.kano2019@gmail.com, 29388_29538_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2024 functional email address is imputed and also the ethical approval letter now have the committee official stamp as requested by the reviewer TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smoh.kano2019@gmail.com, 29388_29538_4737.pdf TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smohdprs@gmail.com, 29388_29538_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/07/2024 The ethical committee reviewed the ethical approval as instructed by the reviewers TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smohdprs@gmail.com, 29388_29538_4737.pdf TRUE, Health Research Ethics Committee Ministry of Health, Post office road, Kano, Kano, 3066, Nigeria, , 12 Apr 2024, +23436921592, smohdprs@gmail.com, 29388_29538_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/06/2024 reviewers recommended that that to be included share IPD 1. The individual participant data will be available at the end of work 2. All of the individual participant data that will be collected during the trial after de-identification 3.No other document will be available aside from the aforementioned 4. Data will be available immediately following publication 5.The Data will be available to any one whom wishes to access it, 6.For any purpose 7.The data will be available indefinitely through a linked document