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CTRI Number  CTRI/2023/06/054265 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 20/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of cardiac rehabilitation on strength and autonomic functions in stroke paitents 
Scientific Title of Study   Evaluating the Efficacy of Exercise-Based Cardiac Rehabilitation in Stroke Patients: A Comparative Analysis of Endurance, Functional Strength, and Autonomic Function 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Sharma 
Designation  Assistant Professor 
Affiliation  MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH & STUDIES 
Address  Department of Physiotherapy, Faculty of Allied health Sciences, Manav Rachna International Institute of Research & Studies, Surajkund Delhi Road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  8826395132  
Fax    
Email  ankitasharma.fas@mriu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Moattar Raza Rizvi 
Designation  Professor and Dean 
Affiliation  Faculty of Allied Health Sciences  
Address  Department of Physiotherapy, Faculty of Allied health Sciences, Manav Rachna International Institute of Research & Studies, Surajkund Delhi Road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9312048470  
Fax    
Email  dean.fahs@mriu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Moattar Raza Rizvi 
Designation  Professor and Dean 
Affiliation  Faculty of Allied Health Sciences  
Address  Department of Physiotherapy, Faculty of Allied health Sciences, Manav Rachna International Institute of Research & Studies, Surajkund Delhi Road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9312048470  
Fax    
Email  dean.fahs@mriu.edu.in  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research & studies, Surajkund Delhi Road, Faridabad, Haryana 
 
Primary Sponsor  
Name  Manav Rachna International Institute of Research & studies 
Address  Department of Physiotherapy, Faculty of Allied health Sciences, Manav Rachna International Institute of Research & Studies, Surajkund Delhi Road, Faridabad, Haryana 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ankita Sharma  Manav Rachna International Institute of Research and Studies  Department of Physiotherapy, Faculty of Allied health Sciences, Manav Rachna International Institute of Research & Studies, Surajkund Delhi Road, Faridabad, Haryana
Faridabad
HARYANA 		 8826395132

ankitasharma.fas@mriu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Commitee, Manav Rachna International Instititute of Research and Studies, Faridabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cardiac Rehbilitation   A structured exercise-based cardiac rehabilitation program tailored to their respective needs and abilities will be administered. The program will aim to improve cardiovascular fitness, endurance, functional strength, and autonomic function.The same will be given for 8 weeks 
Comparator Agent  Stroke specific training  The control group will receive excercises based on stroke rehabilitation. This will be given according to the need of the paitent. The training will be given for 8 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  The study will include patients who meet the following criteria: a confirmed diagnosis of ischemic stroke based on medical records and imaging studies, aged between 40 and 75 years, in the subacute stage of ischemic stroke according to the Burnstrom classification (1 to 3 months post-stroke), medically stable and cleared for exercise by a healthcare professional. Participants should also demonstrate willingness and ability to provide informed consent and possess adequate physical and cognitive abilities to engage in a structured rehabilitation program. Previous participation in a structured cardiac rehabilitation program will be an exclusion criterion.  
 
ExclusionCriteria 
Details  Participants who exhibit severe cognitive impairments that hinder their ability to understand and participate in the study procedures will be excluded. Additionally, individuals with uncontrolled medical conditions that may interfere with exercise participation, such as severe cardiac or respiratory disease, uncontrolled hypertension, or active infections, will not be included in the study. Participants with contraindications to exercise as determined by a healthcare professional, such as recent myocardial infarction, unstable angina, severe arrhythmias, uncontrolled heart failure, or severe orthopedic conditions that prohibit safe exercise, will also be excluded. Those with significant neurological impairments that prevent safe and effective participation in the rehabilitation program, severe comorbidities, or conditions that limit the ability to engage in exercise safely will not be eligible for inclusion. Furthermore, pregnancy will be an exclusion criterion, as exercise prescription may need to be modified for pregnant individuals. Finally, individuals who are unable to provide informed consent or comply with the study procedures will not be included in the study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Endurance, Functional strength & autonomic functions  Baseline & after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Stroke specific quaity of life  Baseline & after 3 months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The objective of this study is to evaluate the efficacy of exercise-based cardiac rehabilitation in stroke patients by assessing the outcomes of endurance, functional strength, and autonomic function. 

A randomized controlled trial will be conducted to compare the effects of exercise-based cardiac rehabilitation between stroke patients and healthy individuals. The study will consist of two groups: an intervention group of stroke patients and a control group of healthy individuals. Both groups will undergo exercise-based cardiac rehabilitation, but the intervention group will include stroke patients while the control group will comprise healthy individuals.

 
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