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.: PACTR201511001359344 Date of Registration: 23/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Nigerian Stroke Aerobic Study (NISAS)
Official scientific title Effects of Interval and Continuous Aerobic Exercise on Clinical Profiles of Stroke Survivors
Brief summary describing the background and objectives of the trial Most stroke survivors live with residual physical impairments, which may promote a sedentary lifestyle with resultant secondary complications. One of the secondary complications commonly observed following a stroke is poor cardiorespiratory fitness. Low cardiorespiratory fitness is related to poor functional performance, increased energy cost of ambulation and increased risk of repeat stroke and cardiovascular disease. Cardiac events and recurrent stroke are major occurrences among stroke survivors. Increasing exercise capacity following a stroke can therefore help prevent deterioration of the cardiovascular system. There is a dearth of studies that have compared physical, cardiovascular, anthropometric and biochemical adaptations to interval and continuous modes of structured aerobic training among stroke survivors. Also, very few studies have assessed the effect of aerobic training on the microscopic profiles such as the biochemical profiles of stroke survivors. This study therefore seeks to compare the effects of interval and continuous aerobic training on selected clinical profiles (physical, cardiovascular, anthropometric and biochemical profiles) of stroke survivors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NISAS
Disease(s) or condition(s) being studied Circulatory System,Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 10/08/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 16/10/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
UPTH/ADM/90/S.II/VOL.X/738 University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Continous Aerobic Training 40-70% of Heart Rate Reserve, three times per week Eight weeks In addition to the conventional physiotherapy treatment, participants cycle using the bicycle ergometer continously for the set time at a target heart rate of 40-70% of their Heart Rate Reserve 14
Experimental Group Interval A work intensity of 40-70% HRR and rest/recovery at 20-29% HRR using a work-recovery ratio of 1:2 (1 minute: 2 minutes). Three times per week 8weeks In addition to the conventional physiotherapy treatment, participants cycle using the bicycle ergometer continously for the set time at a work intensity of 40-70% HRR and rest/recovery at 20-29% HRR using a work-recovery ratio of 1:2 14
Experimental Group Combined Aerobic Training first half (40-70% HRR), second half (work - 40-70% HRR; rest -20-29%HRR at 1:2) 8weeks In addition to the conventional physiotherapy treatment, participants cycle using the bicycle ergometer continously at the first half of the set time at a target heart rate of 40-70% of their Heart Rate Reserve and the second half at intervals (work- 40-70%HRR, rest- 20-29%HRR) 14
Control Group No Aerobic Training N/A N/A Only conventional physiotherapy treatment 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Stroke survivors with a diagnosis of a first-time, unilateral stroke that occurred less than 9months prior to enrollment Stroke survivors who have the ability to walk with/without an assistive device Stroke survivors who have any of the following: acute renal failure, ischemic cardiovascular event or coronary artery bypass surgery less than 3 months prior to the study, uncontrolled blood pressure (resistant hypertension), blood pressure greater than 200/100mmHg, severe peripheral artery disease (ABI < 0.40), diagnosis of congestive heart failure, and a current smoker. Stroke survivors with any other known neurological conditions such as Parkinsons disease. 30 Year(s) 80 Year(s) Male
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 28/09/2015 University of Port Harcourt Teaching Hospital Ethical Committee and the Research Ethics Group of the Centre for Medical Research and Training, College of Health Sciences, University of Port Harcourt.
Ethics Committee Address
Street address City Postal code Country
UPTH Port Harcourt PMB 6173 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VO2max before and after intervention
Primary Outcome Gait speed before and after intervention
Primary Outcome Motor function before and after intervention
Primary Outcome Balance before and after intervention
Primary Outcome Lipid profile (LDL, HDL, TG, Chol, AIP) before and after intervention
Primary Outcome Fasting blood sugar before and after intervention
Secondary Outcome haematological (RBC, WBC, PCV etc) before and after intervention
Secondary Outcome Anthropometric (Conicity Index, Abdominal Volume Index, BMI, WHR etc) before and after intervention
Secondary Outcome Biochemical (urea, creatinine, bilurubin etc) before and after intervention
Secondary Outcome Cardiovascular (BP, Rate Pressure Product, Mean Arterial Pressure, PR etc) before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Department, University of Port Harcourt UPTH Port Harcourt 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Le Professeur Health Services New Haven Enugu 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Le Professeur Health Services New Haven Enugu 23401 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. T.K. Hamzat University of Ibadan Ibadan 23401 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekechukwu E.N.D. nelson.ekechukwu@unn.edu.ng 234-8032298217 UNN
City Postal code Country Position/Affiliation
Enugu 23401 Nigeria Lecturer, University of Nigeria, Enugu Campus, Enugu.
Role Name Email Phone Street address
Public Enquiries Hamzat T.K. talkzat@yahoo.com 234-7031096849 UI
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Professor, University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Ekechukwu E.N.D. nelson.ekechukwu@unn.edu.ng 234-8032298217 UNN
City Postal code Country Position/Affiliation
Enugu 23401 Nigeria Lecturer, University of Nigeria, Enugu Campus, Enugu.
REPORTING
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