| CTRI Number |
CTRI/2021/10/037592 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of Functional Capacity and Fear of Movement in Phase II Coronary Artery Bypass Graft patients. |
|
Scientific Title of Study
|
Correlation between Kinesiophobia and Functional Capacity in Phase II Coronary Artery Bypass Graft patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECARP/2021/48 Version 2 07/05/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal Mistry |
| Designation |
Assistant Professor |
| Affiliation |
TNMC and BYL Nair Hospital |
| Address |
Physiotherapy School & Centre, TNMC and BYL Nair Ch Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027503 |
| Fax |
|
| Email |
hetalmistry1975@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trusha Raje |
| Designation |
Post Graduate Student |
| Affiliation |
TNMC and BYL Nair Hospital |
| Address |
Physiotherapy School & Centre, TNMC and BYL Nair Ch Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8452940012 |
| Fax |
|
| Email |
trusha141096.tr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trusha Raje |
| Designation |
Post Graduate Student |
| Affiliation |
TNMC and BYL Nair Hospital |
| Address |
Physiotherapy School & Centre, TNMC and BYL Nair Ch Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8452940012 |
| Fax |
|
| Email |
trusha141096.tr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School & Centre, TNMC and BYL Nair Ch Hospital, Mumbai Central, Mumbai |
| 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 |
| Hetal Mistry |
Cardiovascular and Thoracic Surgery Out-Patient Department, TNMC and BYL Nair Hospital, Mumbai |
2nd floor, OPD Building, TNMC and BYL Nair Ch Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA |
02223027503
hetalmistry1975@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee For Academic Research Projects (ECARP) PG Academic Commitee, TNMC and BYL Nair Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Both genders.
2.Patients who underwent Coronary Artery Bypass Graft surgery and are 4 weeks post discharge (Phase II).
3.Hemodynamically stable patients.
|
|
| ExclusionCriteria |
| Details |
1.Patients with Congenital heart disease, Valve replacements, Pacemakers
2.Patients with unhealed graft site.
3.Patients unable to comprehend and understand
4.Any psychological illness
5.Major auditory-visual impairments
6.Major post-operative complications
7.Major musculoskeletal or neurological conditions
8.Assistive aids for walking
9.Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Tampa Scale of Kinesiophobia-Short Version Heart (TSK-SV Heart)
2.Six Minute Walk Test |
One time assessment of patients will be done with total duration of assessment not exceeding 45 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/10/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational, cross sectional study to find out correlation between Kinesiophobia and Functional Capacity in Phase II Coronary Artery Bypass Graft patients. The outcome measure that will be used to measure Kinesiophobia is Tampa Scale of Kinesiophobia Heart (TSK-SV Heart). Functional Capacity will be assessed by Six Minute Walk Test (6MWT) |