| CTRI Number |
CTRI/2024/12/078454 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between fear of movement, physical function, mental health and quality of life in patients with Heart Disease
|
|
Scientific Title of Study
|
Association of kinesiophobia with physical function, mental health and health related quality of life in patients with Ischemic Heart Disease – 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 |
Iffat Mohmadali Khatib |
| Designation |
Student Master Of Physiotherapy |
| Affiliation |
MGM Institue of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences , Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India
Raigarh MAHARASHTRA 410209 India |
| Phone |
9324193238 |
| Fax |
|
| Email |
iffatkhatib@mgmsopnm.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Bela Agarwal |
| Designation |
HOD and professor |
| Affiliation |
MGM Institue of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences , Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India
Raigarh MAHARASHTRA 410209 India |
| Phone |
9819000674 |
| Fax |
|
| Email |
bagarwal@mgmsopnm.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Bela Agarwal |
| Designation |
HOD and professor |
| Affiliation |
MGM Institue of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences , Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India
MAHARASHTRA 410209 India |
| Phone |
9819000674 |
| Fax |
|
| Email |
bagarwal@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy, MGM Insitute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences ,Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India |
| 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 Bela Agarwal |
MGM School of Physiotherapy, MGM Insitute of Health Sciences |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209 India Raigarh MAHARASHTRA |
02227437866
bagarwal@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee MGM dental college and hospital |
Approved |
|
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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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
IHD managed conservatively and surgically (PTCA and CABG) |
|
| ExclusionCriteria |
| Details |
Exclusion criteria comprised patients with unstable angina or myocardial infarction within the previous month, impaired cognition, or a resting heart rate exceeding 120 beats per minute. Individuals with systolic blood pressure above 180 mmHg or diastolic blood pressure exceeding 100 mmHg, severe valvular dysfunction, or pain intensity greater than 5 on the Numeric Rating Scale (NRS) were also excluded. Additional exclusions included those with musculoskeletal conditions such as unhealed fractures or osteoarthritis graded above 2, as well as patients diagnosed with neurological disorders (ICD G00-G99) or psychological disorders (ICD F00-F99). |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tampa scale for kinesiophobia |
the outcome measure will be assessed one time as it is cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS scale
NYHA scale
Fatigue severity scale
DASS-21
WHODAS 2.0
IPAQ
WHOQOL-BREF
30 secs sit to stand test
Arm curl test
Back scratch test
Sit and reach test |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="111" Sample Size from India="111"
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)
|
26/01/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This study aims to explore the association of kinesiophobia (fear of movement) with physical function, mental health, and health-related quality of life in patients with Ischemic Heart Disease (IHD). IHD, also known as coronary artery disease, is a leading cause of morbidity and mortality globally, and its prevalence has been increasing in India due to rising risk factors like diabetes, hypertension, and physical inactivity. Kinesiophobia, commonly seen in cardiac patients, can hinder physical rehabilitation, as patients may avoid physical activity due to fear of re-injury or symptoms like angina and shortness of breath. The study will be conducted over 12 months in Navi Mumbai and Raigad districts, involving 111 IHD patients aged 30–75 years. The research will use a cross-sectional design, employing purposive sampling and various validated assessment tools. Key measures will include the Tampa Scale for Kinesiophobia (TSK) to assess fear of movement, and the WHOQOL-BREF, DASS-21, and WHODAS 2.0 to evaluate health-related quality of life, mental health, and disability, respectively. Physical function will be assessed using tests like the 6-minute walk test and muscle strength assessments. Additionally, the study will investigate patients’ knowledge, attitudes, and beliefs about physical activity and its relationship with kinesiophobia. Data will be analyzed using descriptive and inferential statistics to determine correlations between kinesiophobia and the various health outcomes. The goal is to understand how kinesiophobia affects both the physical and psychological aspects of IHD patients’ lives and to identify factors influencing their attitudes toward exercise, with a view to improving rehabilitation adherence and overall quality of life. |