| CTRI Number |
CTRI/2024/09/074118 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating the level of Fear of Movement and Physical activity in the patients who had undergone Valvular surgery - A Survey study. |
|
Scientific Title of Study
|
Evaluation of Kinesiophobia and Physical Activity Levels in Post-Valvular Surgery Patients: A Cross-Sectional 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 |
Subhashini A |
| Designation |
Post Graduate Student (Master of Physiotherapy) |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Narayana Hrudayalaya Foundations, Health city, Bommasandra Industrial area, Anekal taluk, Bangalore-560 099,Karnataka,India.
Bangalore
KARNATAKA
560099
India |
| Phone |
6379273656 |
| Fax |
|
| Email |
subha31lee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Jain N |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Narayana Hrudayalaya Foundations, Health city, Bommasandra industrial area, Anekal taluk, Bangalore-560 099,Karnataka.
Bangalore
KARNATAKA
560099
India |
| Phone |
9791644870 |
| Fax |
|
| Email |
ndjk2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhashini A |
| Designation |
Post Graduate Student (Master of Physiotherapy) |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Narayana Hrudayalaya Foundations, Health city, Bommasandra Industrial area, Anekal taluk, Bangalore-560 099,Karnataka.
Bangalore
KARNATAKA
560099
India |
| Phone |
6379273656 |
| Fax |
|
| Email |
subha31lee@gmail.com |
|
|
Source of Monetary or Material Support
|
| 258/A, Narayana Hrudayalaya Foundations,Narayana Institute of Cardiac Sciences,Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [(.)] |
|
|
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 Subhashini A |
Narayana Health city |
258/A, Narayana Institute of Cardiac Sciences, Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099, Karnataka,India.
Post cardiac surgery ward,
2nd floor,
Room number 2.
Bangalore
KARNATAKA |
6379273656
subha31lee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee(NHAEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Having any type of valvular heart surgery.
2.Being aged 18 - 65 years old.
3.Be able to communicate verbally in English language.
4.At least primary school graduate. |
|
| ExclusionCriteria |
| Details |
1.Having any additional disease that would affect movement after surgery.
2.Having any additional surgeries along with valvular surgery.
3.Having hearing or speaking problems.
4.Having psychiatric illness or treatment for mental disorder.
5.Not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.TAMPA SCALE FOR KINESIOPHOBIA (TSK 17)
2.INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE. (IPAQ SF) |
On 5th Post operative day(POD) after Valvular Surgery.
(at one point of time)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/10/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
1) Aims and Objectives Objective Assess the prevalence of kinesiophobia in post-valvular surgery patients. Assess the physical activity level in post-valvular surgery patients. Analyze the relationship between kinesiophobia and physical activity levels during the postoperative period in valvular surgery patients. Aim The aim of this study is to investigate the association between kinesiophobia and physical activity levels in patients who have undergone valvular surgery, and to assess the prevalence of kinesiophobia and physical activity levels.
2) Hypothesis Null Hypothesis There will be no significant difference in the levels of kinesiophobia and physical activity among patients who underwent valvular heart surgery. There will be no significant correlation between kinesiophobia and physical activity levels in patients who underwent valvular heart surgery. Alternate Hypothesis There will be a significant difference in the levels of kinesiophobia and physical activity among patients who underwent valvular heart surgery. There will be a significant correlation between kinesiophobia and physical activity levels in patients who underwent valvular heart surgery. |