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CTRI Number  CTRI/2025/02/081180 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of fear of movement with physical function, mental health and health related quality of life in patients with restricted airflow and breathing problems 
Scientific Title of Study   Association of kinesiophobia with physical function, mental health and health related quality of life in patients with Chronic Obstructive Pulmonary 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  Ashriya Kailash Juriani 
Designation  MPT Scholar 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel

Raigarh
MAHARASHTRA
410209
India 
Phone  09767610167  
Fax    
Email  ashriyajuriani@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bela Agarwal 
Designation  Professor 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel

Raigarh
MAHARASHTRA
401209
India 
Phone  02227437866  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bela Agarwal 
Designation  Professor 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel

Raigarh
MAHARASHTRA
401209
India 
Phone  02227437866  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 Plot 1 and 2 Kamothe Taluka Panvel, Navi Mumbai -410209 Maharashtra (India) 
 
Primary Sponsor  
Name  MGM INSTITUTE OF HEALTH SCIENCES 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 Plot 1 and 2 Kamothe Taluka Panvel, Navi Mumbai -410209 Maharashtra (India) 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  NOT APPLICABLE 
 
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 Institute of Health Sciences  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy Respiratory OPD IPD Medicine IPD MGM Hospital Sector 1 Plot 1 and 2 Kamothe ,Navi Mumbai-410209 Maharashtra (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 Mahatma Gandhi Missions 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: J40-J47||Chronic lower respiratory diseases,  
 
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  The study will include both male and female patients aged 30 to 75 years who have been diagnosed with Chronic Obstructive Pulmonary disease by chest physician  
 
ExclusionCriteria 
Details  Patients aged over 75 years with unstable angina or a myocardial infarction within the past month are excluded. Other exclusions include a resting heart rate exceeding 120 bpm, systolic BP exceeding 180 mmHg, or diastolic BP exceeding 100 mmHg. Patients with severe musculoskeletal pain with intensity greater than 5, advanced osteoarthritis above grade 2, unhealed fractures, or neurological disorders are not eligible. Additionally, those with impaired cognition, hearing difficulties without aids, or psychological disorders are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tampa scale for kinesiophobia  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NRS scale, MMRC score, Fatigue severity scale, DASS-21, WHODAS 2.0, IPAQ, WHOQOL-BREF, 30secs 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)   04/03/2025 
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 Chronic Obstructive Pulmonary Disease. COPD 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, smoking and physical inactivity. Kinesiophobia, commonly seen in respiratory patients, can hinder physical rehabilitation, as patients may avoid physical activity due to fear of re-injury or symptoms like cough and shortness of breath.

The study will be conducted over 12 months in Navi Mumbai and Raigad districts, involving 111 COPD patients aged 30 to 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  and flexibilty assessments.

Additionally, the study will investigate patient’s 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  COPD patient’s 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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