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.: PACTR202104706858270 Date of Approval: 06/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of moderate-intensity aerobic exercise training on cardiorespiratory parameters among stroke survivors: A randomized controlled trial comparing cycling ergometer with treadmill
Official scientific title Effects of moderate-intensity aerobic exercise training on cardiorespiratory parameters among stroke survivors: A randomized controlled trial comparing cycling ergometer with treadmill
Brief summary describing the background and objectives of the trial Concepts to influence and evaluate aerobic capacity in severely affected individuals with stroke, as well as in the very early period after stroke, are lacking. Further research is needed to develop appropriate methods for cardiovascular rehabilitation after stroke and to evaluate the effects of cardiovascular exercise on aerobic capacity, physical functioning, and quality of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Effects of aerobic exercises in stroke survivors
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 26/04/2021
Actual trial start date 26/04/2021
Anticipated date of last follow up 26/10/2021
Actual Last follow-up date 26/10/2021
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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
Control Group Brunstrom managment of stroke for 30 minutes, 2 times in a week for 8 weeks Passive mobilisation, PNF, stretching and electrical stimulation 15 Active-Treatment of Control Group
Experimental Group Treatmill for 30 minutes, 2 times in a week For 8 weeks Walking on treadmill 15
Experimental Group Ergometer for 30 minutes, 2 times in a week 8 weeks cycling on ergometer 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male ambulatory hemiplegic stroke patients aged between 18 to 65 years old. 2. Ambulatory male hemiplegic stroke patient capable for 6 minutes walk test. 3. Stroke patient with at least Brunnstrom Recovery Stage (BRM) 3 on the lower limb and Modified Asworth Scale between stage +1 to 3 4. Male ambulatory hemiplegic stroke patients willing to participate for the study. 5. Male ambulatory hemiplegic stroke patients who are psychologically oriented 1. Female Stroke patient 2. male stroke patient below the age of 18 and above 65 years of age 3. Presence of red flags (History of cancer, malaise, weight loss, recent infection, bladder and/or bowel dysfunction). 4. Stroke patient with absolute contraindications for cardiopulmonary exercise testing according to American Thoracic Society (ATS) /American College of Chest Physicians (ACCP) criteria such as Unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, febrile illness, 5. Stroke patient with relative contraindications for cardiopulmonary exercise testing according to ATS /ACCP criteria such as cardiac disease, epilepsy, locomotors disorder 6. Male stroke patient with orthopedic conditions such as Limb Length Discrepancy, Fracture, or severe Osteoarthritis knee, Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 22/10/2019 Kano state ministry of health
Ethics Committee Address
Street address City Postal code Country
2nd and 3rd floor, post office road Kano 3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diastolic BP, Systolic BP, Heart rate, Respiratory rate Baseline and weeks 8 and 12
Secondary Outcome Oxygen saturation, gait speed, VO2 max Baseline and weeks 8 and 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed specialist hospital kano Hospita road, kano Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nasir Musa Machina Road, FMC Nguru Yobe 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nasir Hassan Machina road Nguru 630101 Nigeria Self sponsorship
COLLABORATORS
Name Street address City Postal code Country
Musa Sani Danazumi Machina Road FMC, Nguru Yobe 630101 Nigeria
Ahmad Rufai Bama road, university of maiduguri teaching hospital Borno 1414 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nasir Hassan abumuhibbat17@gmail.com 07051796366 Machina road, Nguru
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Principal physiotherapist
Role Name Email Phone Street address
Public Enquiries Musa Sani Danazumi musadanazumisani@gmail.com 07051796366 Machina road, Nguru
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Adamu Rufai adamuarufai@unimaid.edu.ng 08109607918 Bama road, maiduguri
City Postal code Country Position/Affiliation
Maiduguri Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All patients outcome data, statistical plan, informed consent, clinical study report, and summary results Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol January 2022 Publication
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