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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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). 
 
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.

 
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