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.: PACTR201903762696119 Date of Approval: 18/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Walking Exercise on Brain-Derived Neurotrophic Factor, Cognition, Participation and Quality of Life among Stroke Survivors
Official scientific title Walking Exercise Versus Cognitive Rehabilitation Protocols on Brain-Derived Neurotrophic Factor, Cognition, Participation and Quality of Life among Stroke Survivors
Brief summary describing the background and objectives of the trial Background Neurological deficits following a stroke include motor, sensory/perceptual and cognitive impairments (Lawrence et al, 2001). Stroke is regarded as the second most common cause of cognitive impairment (Qu et al., 2015). Studies have shown that aerobic exercise administered through treadmill or cycle ergometer is effective in the management of cognitive impairment post-stroke. However, there are limited stroke rehabilitation material and human resources in most African countries (Olawale et al., 2011). Furthermore, overground walking, a relatively cheap form of aerobic exercise is more effective than treadmill training and can be employed as a therapeutic modality for stroke survivors especially where there are no facilities such as treadmill or bicycle ergometer. In view of the foregoing, a randomised control trial investigating the effects of overground walking on outcomes such as biochemical factor (BDNF), cognitive function, participation and quality of life of stroke survivors will be conducted. The aims of this study are to: a. Investigate the effects of 8-week over-ground walking exercise on brain-derived neutrophic factor, cognition, participation and quality of life of cognitive-impaired stroke survivors b. Investigate the effects of 8-week cognitive rehabilitation protocol on brain-derived neutrophic factor, cognition, participation and quality of life of cognitive-impaired stroke survivors c. Investigate the effects of combined 8-week over-ground walking exercise and cognitive rehabilitation on brain-derived neutrophic factor, cognition, participation and quality of life of cognitive-impaired stroke survivors d. Compare the effects of 8-week over-ground walking exercise, cognitive rehabilitation protocol, combined treadmill training and cognitive rehabilitation protocol on brain-derived neutrophic factor, cognition, participation and quality of life of cognitive-impaired stroke survivors
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 18/03/2019
Actual trial start date 15/04/2019
Anticipated date of last follow up 30/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 57
Actual target sample size (number of participants)
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined Rehabilitation Protocol 3 times per week 8 weeks The combined interventions will be conducted in two parts. First part will include the over-ground-walking exercise while the second part will include the cognitive rehabilitation as follows: OVER-GROUND WALKING EXERCISE An 8 week moderate intensity of over-ground walking exercise adapted from Olawale et al., (2011) will be conducted on a flat surface with 15 by 10 metre dimensions. The participants will walk to and fro in the gymnasium at moderate intensity of 40 to 59% of HRR and/or a rating of perceived exertion of 12 to 13 on the Borg 6-20 Scale (Franklin and Swain, 2003). The upper and lower limit of the intensity will be set on a wrist heart rate monitor to keep the participants within the desired intensity. Exercise would be terminated any time the participants reported symptoms of exertional intolerance that is outside the target zone on Borg’s rate of perceived exertion (RPE) scale (See Appendix 9). The intensity will be kept constant while the duration of the exercise session will be progressed from 15 minutes in the first week to 50 minutes in the 8th week as shown in (Appendix 11). There will be warm-up and warm-down periods for 5 minutes each at the intensity of 30% of HRR prior to commencement and as well towards the end of the training session (Macko et al, 1997). Prior to the commencement of the exercise, familiarization with various parameters of the exercise for effective execution of the exercise will be conducted for the participants. The intensity of the exercise will be determined using the HRR method of Karvonen and associates as summarized in appendix 12: THR= (HR max- HR rest) x (desired intensity) + HR rest Where; 1. Maximum Heart Rate (HR max) = will be computed using the formula; HR max =220-age 2. Heart Rate Rest (HR rest) =The Resting Heart Rate will be measured in the gymnasium with a comfortable temperature, avoiding any background noise such as telephones or beepers. The participant will be comfortably seated in a chair with back supported and arm positioned at heart level, the legs uncrossed and flat on the floor. A rest period of 5 minutes will be given before readings. The cuff will be wrapped around the arm of the participant. Start button on the apparatus will be pressed and the readings from the screen will be recorded and documented on the data information sheet. The Measurement procedure will take about 2 minutes to complete. At least two measurements in the sitting position will be taken. Readings will be obtained from both write and left arms. The arm with the highest average will be used for all subsequent measures. Participants will be instructed to refrain from alcohol consumption and exercise on the day of attending the BP clinic, and to avoid smoking and caffeine consumption 3 hours prior to attendance. 3. Heart rate reserve (HRR) = Maximum heart rate – resting heart rate 4. Desired intensity= 40 to 59% of HRR DRESSING PRACTICE (PUTTING ON A BUTTON UP SHIRT WITH ONE HAND) Developed by the Department of Rehabilitation, Ohio State University Medical Center (2009) for patients with cognitive impairments and dressing problem. The procedure is carried out using the unaffected upper limb in a firm chair and it involves two stages (putting and removing the shirt). The treatment will be administered for duration of 45 minutes, three times in a week for a period of 8 weeks. The instructions for administering dressing practice include the following steps: Putting the shirt on: i. Use your strong non-affected hand and pick up the shirt by the collar and shake it to untwist it. j. Spread the shirt out over your lap with the inside facing up and the collar next to your abdomen. (Shirt tail will drape over your knees) k. Open the sleeve opening of the shirt as much as you can on the weak arm side. l. Pick up the weak hand with your strong hand. Place the weak hand into the sleeve opening. m. Pull the sleeve up over your elbow on your weak side. n. Fo 19
Experimental Group Aerobic exercise 3 times a week 8 weeks An 8 week moderate intensity, over-ground walking exercise adapted from the study of Olawale et al., (2011) will be conducted on a flat surface of 15 by 10 metre dimensions. The participants will walk to and fro in the gymnasium at moderate intensity of 40 to 59% of HRR and/or a perceived exertion rating of 12 to 14 on the Borg 6-20 Scale. The upper and lower limit of the intensity will be set on a heart rate (wrist type) monitor to keep the participants within the desired intensity. Exercise would be terminated any time the participants reported symptoms of exertional intolerance that is outside the target zone on Borg’s Rate of Perceived Exertion (RPE) scale. The intensity will be kept constant while the duration of the exercise session will be progressed from 15 minutes in the first week to 50 minutes in the 8th week. There will be warm-up and cool-down periods of 5 minutes each at an intensity of 30% of HRR at commencement and towards the end of the training session 19
Control Group Cognitive rehabilitation 3 times per week 8 weeks Group B: (Cognitive Rehabilitation) The cognitive intervention adapted from Zoltan (2007) to address cognitive skills for the cognitive-impaired stroke survivors will be used in this study. Procedure of the cognitive intervention The therapy will be for a period of 8weeks. During each week, the cognitive intervention will be conducted on alternative days within the official working days (3times in a week). Each session will last for a period of 30minutes. The therapy time in each session will be divided into two categories. The schedule is as follows: Attention: The first phase involves intervention for attention. All the participants will be assembled assigned cancellation task (table top). The task will be collected afterward and patient’s performance will be graded. The task performed will be scored after completion. Memory: The second phase will include intervention to improve participant’s memory. Task that utilizes Preview, Question, Read, State, Test (P. Q. R. S. T) method will be used. Participants will also be scored at the end of the task. The intervention for the cognitive skills will be divided into two phases as per the degree of task complexity. The first phase will be for a period of four weeks. The cognitive tasks will be simplified and conducted in a room free from environmental distraction. The second phase will be for another period of four weeks in which the tasks will be modified and there will be inclusion of environmental distraction to make it more challenging. 19 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. First incidence of ischaemic or haemorrhagic stroke with blood pressure under control 2. cognitive function score of 10 to 25 on the Montreal Cognitive Assessment (MoCA) 3. Adequate balance control of less than 30 seconds scores indicated by Timed Up-and-Go (TUG) test 4. Able to read and write in either English or Hausa language 5. Mild to moderate upper limb impairment with wrist, metacarpophalangeal and interphalangeal joint extension of more than 20 degrees and preserved ability to grasp 7. Able to complete self-paced 6 Minutes Walk (6MW) test at an intensity of perceived exertion of 12 to 13 on the Borg 6-20 Scale. a) Individuals with severe cardiac problems as determined using physical activity readiness questionnaire and aerobic exercise testing. This group of participants may not be able to cope with the exercise intensity. b) Individuals with severe depression as indicated by Physical Health Questionnaire (PHQ) score of more than 15 and stroke survivors with other conditions that may cause cognitive impairments such as Parkinson’s disease, Alzheimer’s disease or traumatic head injury etc. c) Individuals with severe joint disorders such as osteoarthritis, rheumatoid arthritis that may become worse during exercise or can make performance of exercise difficult. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 02/04/2019 Research Ethics committee Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Hospital road Kano 700233 Nigeria
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 15/03/2019 Human Research Ethics Committee Ministry of Health Kano state
Ethics Committee Address
Street address City Postal code Country
Post office road Kano 700213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognition Initial, 4th and 8th week
Primary Outcome Brain-derived neurotrophic factor Initial, 4th and 8th week
Secondary Outcome Quality of life Initial, 4th and 8th week
Secondary Outcome Participation Initial, 4th and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist Hospital Emirs Palace road Kano Nigeria
Muhammad Abdullahi Wase Specialist Hospital Hospital road Kano Nigeria
Aminu Kano Teaching Hospital Hospital road Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano Gwarzo road Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero Uiversity Kano Gwarzo road Kano Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammad Aliyu Abba maabba.pth@buk.edu.ng +2348030484034 Gyadi-gyadi
City Postal code Country Position/Affiliation
Kano Nigeria Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Talhatu Kolapo Hamzat talkzat@yahoo.com +2347031096849 Dugbe
City Postal code Country Position/Affiliation
Ibadan Nigeria University of Ibadan Nigeria
Role Name Email Phone Street address
Public Enquiries Olubukola A. Olaleye olubukolaolaleye@yahoo.com +2348100965871 Dugbe
City Postal code Country Position/Affiliation
Ibadan Nigeria University of Ibadan Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Age, gender, tribe, occupation, education Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year request access will be controlled, descriptive and and inferential statistics will be used, request through contact of the principal investigator to be decided by third party and reviewed by a Professor
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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