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.: PACTR202008538252779 Date of Approval: 27/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Cardiorespiratory Fitness on Walking Performance in Chronic Hemiplegic Patients with Myocardial Infarction
Official scientific title Influence of Cardiorespiratory Fitness on Walking Performance in Chronic Hemiplegic Patients with Myocardial Infarction
Brief summary describing the background and objectives of the trial Background: Concurrence of acute ischemic stroke and myocardial infarction is serious in clinical scenarios. The purpose of this study was to determine the influence of cardiorespiratory fitness on walking performance in chronic hemiplegic patients with myocardial infarction.
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 The Cardiorespiratory Fitness
Anticipated trial start date 30/08/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional physical therapy Three times per week for 45 minutes per session for 4 weeks • Relaxation technique for spastic muscles. • Facilitatory technique for antispastic muscles • Stretching exercise to prevent shortening. • Proprioceptive Neuromuscular Facilitation (PNF). • Trunk control training. 20 Active-Treatment of Control Group
Experimental Group cardiorespiratory fitness in addition to traditional physical therapy three times per week for 45 minutes per session 4 weeks o Treadmill training: Patients obtained cardiorespiratory fitness through speed range from 0.6 to 1.3KM/H, 0°incline and no resistance (DURATION). o Calisthenic exercise: is a type of exercise consisting of number of movements exercising large muscle groups, such as sit-up, standing, grasping, moving, etc. As bodyweight exercises, these exercises are often performed with minimal equipment and rhythmically. They are intended to improve strength, endurance and flexibility by using one's body weight for resistance through movements such as pulling, pushing, jumping, bending or swinging. In addition to enhancing psychomotor skills such as balance, agility and coordination. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Forty chronic hemiplegic patients (more than 6 months) with myocardial infarction patients, of both gender The inclusion criteria included independently ambulant patients with mild spasticity (according to Modified Ashwarth scale: appendix I) were selected. The exclusion criteria included any patient had a contraindication for stress test (acute myocardial infarction, acute myocarditis or pericarditis, sever aortic stenosis, unstable angina, chronic heart failure, or musculoskeletal problems that could prevent the patient during stress test), patients with recurrent stroke, Parkinsonism, severe osteoarthritis, and rheumatoid arthritis, and patients with aphasia, blindness, deafness, and patients who did not follow instructions. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 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 10/06/2020 Ethical Committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stress test before the beginning baseline and after 4-weeks post-test
Secondary Outcome 10-meter walking test Before the beginning baseline-test and after 4-weeks post-test
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Modern University for Technology and Information Cairo Egypt Abageyah, El Mukkatam, Cairo, Egypt Cairo 11571 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadeee 51 Toson Street Shoubra Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Toson St. Shoubra Cairo 11672 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Toson Street Shoubra Cairo 11672 Egypt
Ahmed El Shinnawy Al Abageyah, El Mukkatam, Cairo, Egypt Cairo 11571 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Wadee anazih@cu.edu.eg 01222367919 51 Toson Street Shoubra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Ahmed El Shinnawy el_shinnawy80@hotmail.com 01092070555 Street 9, Al Abageyah, El-Khalifa, Cairo Governorate
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Islam Fayed dislamhasan@gmail.com 01097279742 Street 9, Al Abageyah, El-Khalifa, Cairo Governorate
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Lecture
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Publication in an international journal Statistical Analysis Plan,Study Protocol within one year open access
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