| 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
|
|
|
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. |