| CTRI Number |
CTRI/2019/03/017906 [Registered on: 01/03/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The benefits of a planned activities on heart functions and quality of life after heart operation. |
|
Scientific Title of Study
|
Effectiveness of a Cardiac Rehabilitation programme on physiological parameters and quality of life among post operative cardiac surgery clients admitted in selected hospital of Ahmednagar, Maharashtra. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Amol C Temkar |
| Designation |
Associate Professor |
| Affiliation |
Dr.V.V.P.Fs College of Nursing |
| Address |
Post operative ICU no 2, Sindhutai Cardiac Center, Dr VVPFs Memorial Hospital
Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890787219 |
| Fax |
|
| Email |
amoltemkar09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Amol C Temkar |
| Designation |
Associate Professor |
| Affiliation |
Dr.V.V.P.Fs College of Nursing |
| Address |
Post operative ICU no 2, Sindhutai Cardiac Center, Dr. VVPFs Memorial Hospital
Vilad Ghat
Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890787219 |
| Fax |
|
| Email |
amoltemkar09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheshwari S Harishchandre |
| Designation |
Associate Professor |
| Affiliation |
Dr.V.V.P.Fs Memorial Hospital |
| Address |
Post operative ICU No 2, Sindhutai Cardiac Center, Dr.VVPFs Memorial Hospital
Vilad Ghat
Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9130054937 |
| Fax |
|
| Email |
maheshwariharishchandre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sindhutai Cardiac Centre
Dr VVPFs Memorial Hospital
MIDC
Vilad Ghat
Ahmednagar
414111 |
|
|
Primary Sponsor
|
| Name |
Dr VVPFs Memorial Hospital |
| Address |
Dr.V.V.P.Fs Memorial Hospital
Vilad Ghat
Ahmednagr |
| Type of Sponsor |
Private 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 |
| Dr Maheshwari S Harishchandre |
Sindhutai Cardiac Centre Ahmednagr |
Post operative ICU no 2, Cardiac Department, Dr VVPFs Memorial Hospital
Vilad Ghat
Opp Govt Milk Dairy
MIDC
Ahmednagar
Pin Code - 414111
Ahmadnagar
MAHARASHTRA |
9130054937
maheshwariharishchandre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pravara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I971||Other postprocedural cardiac functional disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cardiac Rehabilitation Programme |
Designed Cardiac Rehabilitation with selected required exercises and health education will be introduced to post operative cardiac surgery client in three different phases for a period of ten weeks |
| Comparator Agent |
Routine care protocol |
Routine care protocol will be introduced to the post operative cardiac surgery clients for a period of ten weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Client undergone Cardiac Surgery
2 Client with second post operative day and stable hemodynamics
3 Client who will able to follow instructions
|
|
| ExclusionCriteria |
| Details |
1 Client who is critically ill and unable to follow a cardiac rehabilitation programme
2 Client who developed secondary complications due to cardiac surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in cardiac functions and quality of life according to WHOQOL brief |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in activity tolerance and life expectancy |
2 years followup |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="540"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives of the study: 1. 1. To assess the physiological parameters and quality of life among post operative cardiac surgery clients. 2. 2. To assess the effectiveness of a cardiac rehabilitation programme on physiological parameters and quality of life among post operative cardiac surgery clients. 3. 3. To correlate the physiological parameters and quality of life of post operative cardiac surgery clients with their selected sociodemographic variables and clinical variables Hypothesis: H1: There will be significant change in physiological parameters and quality of life among post operative cardiac surgery clients after introduction of a cardiac rehabilitation programme. H2: There will be significant association between physiological parameters and quality of life of post operative cardiac surgery clients with their sociodemographic variables and clinical variables. Trial will be based on Emogen Kings Goal Attainment theory Trial will be analysed through descriptive and inferential statistics. |