FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068230 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To check the functional ability of patient and Quality of life by giving Cardiac Rehabilitation to patients with heart surgery 
Scientific Title of Study   Evaluation of Remote Phase-2 Cardiac Rehabilitation on Functional Capacity and Health-Related Quality of Life in Patients Post Valvular Heart Surgeries at Tertiary Care Hospital: A Quasi-experimental study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariya Jiandani 
Designation  Associate Professor 
Affiliation  Seth G S Medical college and KEMH 
Address  Physiotherapy School and Centre, Seth G S Medical college Opposite Tata hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820191106  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mariya Jiandani 
Designation  Associate Professor 
Affiliation  Seth G S Medical college and KEMH 
Address  Physiotherapy School and Centre, Seth G S Medical college Opposite Tata hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820191106  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijaya Bhurke 
Designation  P G student 
Affiliation  Seth G S Medical college and KEMH 
Address  Physiotherapy School and Centre, Seth G S Medical college Opposite Tata hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9146913569  
Fax    
Email  vijayabhurke8457@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical college & KEM Hospital parel east Mumbai 12 
 
Primary Sponsor  
Name  Physiotherapy school and center Seth G S Medcial college and KEMH 
Address  Physiotherapy School and Centre, Department of Cardiology Seth G S Medical college Opposite Tata hospital Parel east Mumbai 12 
Type of Sponsor  Government medical college 
 
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 
Mariya Jiandani  Physiotherapy School and Centre Seth G S Medical college  Room no. 16 Ground floor CVTC OPD Physiotherapy School and Centre, Department of Cardiology Seth G S Medical college Opposite Tata hospital Parel east Mumbai 12
Mumbai
MAHARASHTRA 
9820191106

mpjiandani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth G S Medical Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I342||Nonrheumatic mitral (valve) stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Software driven intervention group.  The patient should have a smartphone and should be able to operate it. Patient with basic reading skills (English, Hindi, Marathi). Baseline assessment - the following data will be recorded: demographic data, functional capacity assessed by a 6-minute walk test, quality of life will be assessed by the EQ5D scale and current medication. This group has an Android phone and will have to install an app to provide digital interphase. This digital Health is provided free of cost by using the digital health app from Lupin. All the data will be protected as per the HIPAA policy. Individual exercise programs will be done by PI and CO PI based on the initial assessment of the FITT (Frequency, Intensity, Time, and Type) principle as in usual care Education sessions and relaxation videos will be provided online. The patient will be requested to download the Google Fit app to keep track of the number of steps Videoconferencing (on WhatsApp or Zoom) would be conducted to monitor the health condition and exercise program once a week. Telephonic consultation regarding physical activity and exercise, and adherence monitoring (medication changes) will conducted weekly 
Comparator Agent  Usual care group  Patients who do not have experience operating a smartphone. Patients with basic reading skills. Baseline assessment - the following data will be recorded- demographic data, functional capacity assessed by 6-minute walk test, quality of life assessed by the EQ5D scale, and current medication. AT Discharge participants in this group will provide customised exercise plans based on the initial assessment in print form. Nutritional counseling will be done. Relaxation techniques or video or audio will be given to the group. Telephonic consultation regarding physical activity and exercise, and adherence monitoring (medication changes) will be conducted weekly. A diary will be given for the exercise, and follow-up will be taken at 6 weeks and 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Elective left-sided or right-sided heart valve surgery (aortic, mitral, tricuspid, and
pulmonary valve repair and replacement)
2. Double-valve surgery
3. Combined Valve + CABG surgery
4. Age between 18 and 60 years old
5. Both males and females were included  
 
ExclusionCriteria 
Details  1. Cognitive impairments like dementia
2. Patients with left ventricular dysfunction.
3. Patients who had persistent or paroxysmal atrial fibrillation
4. Patients with unstable postoperative hemodynamics.
5. Patients who have any lower limb deformity due to which they are unable to walk
6. Participants who do not consent to participants
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.6-minute walk test
2.EQ-5D Quality of life
 
Baseline
6 week
12 week
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Questionnaire for the satisfaction and adherence  Baseline
6 week
12 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction: Valvular heart disease that leads to obstruction or backwards flow of blood. Heart valve surgery is a well-known procedure. Patients undergoing heart valve surgery who have postoperative complications commonly present with impairment of physical activity and physical capacity up to several years before surgery combined with a period of bed rest, which leads to muscle weakness after surgery and affects their functional capacity and quality of life. Cardiac rehabilitation is a comprehensive programme that emphasises secondary prevention and lifestyle changes. Centre-based rehabilitation is the gold standard, but due to travel problems, financial problems, and limited resources, it is difficult to attend the exercise programme. Nowadays, smartphones and wearable devices are used to monitor exercises at home.

 Aims and objectives: The study aims to evaluate the effects of remote phase 2 cardiac rehabilitation over usual care on functional capacity and quality of life in valvular heart surgery patients older than 18 to 60 years old.

Methodology: patients undergoing post-valvular Heart surgery will be included and written consent will be obtained. Patients are divided into 2 groups: the software-driven cardiac rehabilitation group and the usual care group.at discharge demographic data, 6 MWT, and Quality of life will be assessed. software-driven intervention group, Cardiac rehabilitation through the Digital Health app. Telephonic consultation is given once a week, an individual exercise programme will be made, relaxation videos will be given, and for the usual care group exercise programme, patient education will be given. A routine follow-up will be done. re-evaluation of both groups at 6 and 12 weeks at the end of the study, reassessment of 6MWT, And the quality of life will improve. The adherence and satisfaction of the remote intervention group will be measured.  The collected data will be analysed. 

 
Close