| 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
|
|
|
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
|
|
|
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. |