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.: PACTR202001495245937 Date of Approval: 16/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Moderate Aerobic Exercise and Inspiratory Muscle Training on selected Clinical and Haematological Parameters Among Adults with Sickle Cell Disease
Official scientific title Effects of Moderate Aerobic Exercise and Inspiratory Muscle Training on selected Clinical and Haematological Parameters Among Adults with Sickle Cell Disease
Brief summary describing the background and objectives of the trial Sickle cell disease (SCD) is a general term for a group of genetic disorders characterized by the predominance of sickle cell hemoglobin, HbS (John, 2010). Sickle cell anaemia (SCA) refers to homozygous sickle hemoglobin (HbSS) state, it remains the most common and severe form (Quinn, Rogers & Buchanan, 2004). HbSS is caused by inheritance of homozygous mutant haemoblobin S (HbS), and accounts for 60-75% of the patients with SCD (Gladwin, & Taylor, 2008). SCA remains a major genetic disease in most countries in Sub-Saharan Africa, Nigeria inclusive (WHO, 2015). The prevalance is highest in Nigeria making Nigeria the country with highest number of SCA in the world and Africa patients than any other country in the world (Therrell & Hannon, 2006; Sagir et al, 2010). HbSS genotype is associated with more severe hemolytic anaemia and increased risk of cardiovascular and pulmonary complications than the heterozygous sickle hemoglobin genotype (Gladwin, & Taylor, 2008). These complications represent a diverse group of diseases affecting the large and small airways parenchyma, vasculature and are leading and early causes for morbidity and mortality in this population (Mehari & Kling, 2016). They are characterized by disorders such as chronic dyspnea, asthma, recurrent wheezing without a diagnosis of asthma, cough, pulmonary hypertension, pulmonary fibrosis, thrombo-embolic disease, abnomnal lung function and sleep-disordered breathing (Machado & Gladwin, 2005). Physical exercise is considered to be an important supplementary modality in the treatment of different chronic diseases (Adegoke, Akinola & Oyeyemi, 2015). Also, inspiratory muscle training is shown to be useful in management of respiratory conditions(Weiner, 1992). However, both of these interventions are sparsely used as an entity or a combination in this population despite their benefits, therefore, this study intends to explore the combined
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/01/2022
Actual trial start date 10/01/2022
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date 03/08/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 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 Moderate aerobic exercise 3 times weekly 8 weeks This group will serve as group 1 The protocol will consist of 2 parts: 1. Exercise testing 2. Moderate Aerobic exercise training 1. Exercise testing: The exercise testing will be adopted from the work of Balaysaac-sirancy et al (2011) and Gellen et al (2018). It will consist of 5 minutes warm up exercise, followed by exercise test at 20W. The exercise load will be increased by 0.15watts/body kg weight every 2 minutes until volitional exhaustion is reached. The maximum/peak work rate reached in watts will be recorded for each individual at the time of exhaustion, this will be followed by 5 minutes cool down. 2. Moderate aerobic exercise training (MAE): Main exercise The MAE training will be conducted for 30 minutes, 3 times weekly for a period of 8 weeks. Warm-up will be 5 minutes and cool down 5 minutes. The training load will be 60% of peak work rate determined during the pre-test session in the 1st 2-weeks, it will be progressed every 2 weeks as follows: Week Peak work rate 1-2 60% of peak work rate 3-4 70% of peak work rate 5-6 80% of peak work rate 7-8 90% of peak work rate 20
Experimental Group Moderate aerobic exercise plus inspiratory muscle training 3 times weekly 8 weeks Participants in this group will receive moderate aerobic exercise plus inspiratory muscle training. The moderate aerobic exercise will be the same as group 1 The Maximal Inspiratory Pressure will be determined first with a respiratory pressure gauge (VACUMED) according to the protocol described by American Thoracic Society & European Respiratory Society statement on Respiratory muscle testing. In the first training week, the Inspiratory Muscle Training will be conducted at 30% of Maximal Inspiratory Pressure generated for each participant. The frequency of the training in each session will be 5 sets of 6 inspirations with 2 minutes of rest between set. The training load of 5MIP will be increased weekly with the number of sets remaining constant The progression is as follows. Week ------------------------------------------------- MIP 1stweek--------------------------------------------- --30% 2nd week----------------------------------------------35% 3rd week----------------------------------------------40% 4th week----------------------------------------------45% 5th week----------------------------------------------50% 6th week----------------------------------------------55% 7th week----------------------------------------------65% 8th week----------------------------------------------70% 20
Control Group Medication only The dose will be determined by the Haematologist 8 weeks The participants in this group will be group 3. The participants will be on their standard of care drugs (Palodrine and Folic acid), they will serve as control group. They will not participate in the moderate aerobic exercise or the combination of both moderate aerobic exercise and inspiratory muscle training 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Diagnosis of Sickle Cell Disease type HbSS following electrophoresis test 2. Restricted pattern of spirometry. 3. Adults, aged 18 years and above who are able to perform pulmonary function test. 4. Patients who can understand instructions on how to carry out the procedure involved in this study 5. A non-smoker Sickle Cell Anaemia (SCA) patient. 6. Steady state patients that have not had crises for at least 1 month and no blood transfusion. 7. Individuals with no prior asthma history. 1. Chronic lung diseases unrelated to sickle cell disease, such as COPD, asthma 2. Heart disease and pulmonary hypertension 3. Individuals with avascular necrosis 4. Individuals on hydroxyuria drug Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Both
1. Diagnosis of Sickle Cell Disease type HbSS following electrophoresis test 2. Restricted pattern of spirometry. 3. Adults, aged 18 years and above who are able to perform pulmonary function test. 4. Patients who can understand instructions on how to carry out the procedure involved in this study 5. A non-smoker Sickle Cell Anaemia (SCA) patient. 6. Steady state patients that have not had crises for at least 1 month and no blood transfusion. 7. Individuals with no prior asthma history. 1. Chronic lung diseases unrelated to sickle cell disease, such as COPD, asthma 2. Heart disease and pulmonary hypertension 3. Individuals with avascular necrosis 4. Individuals on hydroxyuria drug Adult: 19 Year-44 Year 18 Year(s) 44 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 08/02/2019 Hospital Research Ethics Committee Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Zaria Road, Kano, Kano State Kano 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lung Function Test The outcome will be measured at baseline, 4th week and 8th week
Secondary Outcome Respiratory muscle strength, Functional capacity, Quality of life, respiratory symptoms, Full blood count and Lactate Dehydrogenase The outcome will be measured at baseline, 4th week and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist Hospital Kano State Rimi Market Road, Kano, Kano State Kano 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
Dr Musa Maiyaki Zaria road Kano 700233 Nigeria
Ahmed Isyaku Zaria Road Kano 700233 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AISHAT SHITTU ashittu.pth@buk.edu.ng +2348036785233 Gwarzo road, Kano
City Postal code Country Position/Affiliation
Kano 700241 Nigeria Lecturer Bayero University Kano
Role Name Email Phone Street address
Public Enquiries AISHAT SHITTU ashittu.pth@buk.edu.ng +2348036785233 Gwarzo road, Kano
City Postal code Country Position/Affiliation
Kano 700241 Nigeria Lecturer Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries RUFUS ADEDOYIN radedoyi@yahoo.com +2348033829978 Ibadan road, Ile-Ife
City Postal code Country Position/Affiliation
Ile Ife Osun Nigeria Professor Obafemi Awolowo University Ile Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial such as text, tables, figures, and appendices), will be available after deidentification. Study Protocol, Statistical Analysis Plan, Analytic Code will be available from 3 months to 5 years following article publication to all persons that want to use it for meta analysis. Proposals should be directed to ashittu.pth@buk.edu.ng via https://drive.google.com/open?id=1kz5gtSmHZigObhhrWO86YxC2L1temVXl Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Proposals should be directed to ashittu.pth@buk.edu.ng. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website via https://drive.google.com/open?id=1kz5gtSmHZigObhhrWO86YxC2L1temVXl
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/open?id=1kz5gtSmHZigObhhrWO86YxC2L1temVXl 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