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CTRI Number  CTRI/2023/08/056561 [Registered on: 16/08/2023] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of Multi-condition on Mobility-Disability after Cardiac Device Implantation 
Scientific Title of Study   Influence of Multimorbidity on Mobility-Disability following Cardiac Device Implantation 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrunal Dhore 
Designation  Postgraduate student 
Affiliation  Manipal College of Health Professions MCHP 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  7020514037  
Fax    
Email  dhoremrunal06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abraham Samuel Babu 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions MCHP 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9742502838  
Fax    
Email  abrahambabu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Nivedita S Prabhu 
Designation  Assistant Professor (Selection Grade) 
Affiliation  Manipal College of Health Professions MCHP 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9901726546  
Fax    
Email  nivedita.kamath@manipal.edu  
 
Source of Monetary or Material Support  
NONE 
 
Primary Sponsor  
Name  Miss Mrunal Dhore 
Address  Department of Physiotherapy, Manipal College of Health Professions MAHE Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
Miss Mrunal Dhore  Kasturba Hospital Manipal  room number 32 third floor Department of Physiotherapy Cardiac Rehabilitation Clinic of Department of Cardiovascular and Thoracic Surgery Kasturba Hospital Manipal
Udupi
KARNATAKA 
7020514037

dhoremrunal06@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I459||Conduction disorder, unspecified, (2) ICD-10 Condition: I519||Heart disease, unspecified, (3) ICD-10 Condition: I443||Other and unspecified atrioventricular block, (4) ICD-10 Condition: I458||Other specified conduction disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Participants with presence of multimorbidity
screened using Charlson Comorbidity Index and between age group of 40 to 60 years
of either gender who are scheduled for device implantation surgery 
 
ExclusionCriteria 
Details  Individuals with acute myocardial infarction, patients in cardiogenic shock patients with known psychiatric conditions patients with any neurological or musculoskeletal condition affecting the mobility and
patients who are bed bound prior to the surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mobility-Disability Scale
 
at postoperative day one
at 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Charlson Comorbidity Index of multimorbidity  at admission 
Six Minute Walk Test for functional capacity  at admission at discharge 
Tampa Scale Kinesiophobia Heart  at admission at discharge  
Mi bands for physical activity  from post operative day one to day of discharge 
EQ 5D 5L for quality of life  at discharge
at 1 month after discharge 
MACE  at 1 month follow up 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   20/08/2023 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The following study is an observational study with a purpose of finding the influence of multimorbidity on mobility disability following any device implantation surgeries. Participants will be screened from the age group of 40 to 80 years of either gender for presence of multimorbidity using the Charlson Comorbidity Index who will be undergoing device implantation surgeries. Individuals with acute myocardial infarction, patients in cardiogenic shock, patients with known psychiatric conditions, patients with any neurological or musculoskeletal condition affecting the mobility and patients who are bed bound prior to the surgery will be considered under the exclusion criteria. Patients will also be screened for physical activity based on step counts using the Mi bands that being partially funded by the Heart Failure Association of India, functional capacity based on 6-minute walk test distance, Kinesiophobia based on Tampa scale Kinesiophobia Heart, health related quality of life using the EQ5D5L.

Permission will be sought from the respective developers of Charlson Comorbidity Index, Mobility-Disability Scale, Tampa Scale Kinesiophobia-Heart and EQ-5D-5L questionnaire. Permission will be taken from the Institutional Research Committee, Manipal and ethical clearance will be sought from the institutional Ethics Committee, Kasturba hospital, Manipal. Following this registration of the study protocol will be done in Clinical Trail Registry-India (CTRI) will be done before commencement of the study. Patients will be screened for the inclusion criteria from the department of electrophysiology division cardiology before the surgery and consent will be obtained from the potential individuals. Demographic details and other required variables of the included patients will be obtained from the medical records from the hospital database. Participants posted for the device implantation surgery will be screened for the presence of multimorbidity using the Charlson Comorbidity Index prior to cardiac implant surgery. Post-operatively patients will be assessed for mobility using the Mobility-Disability Scale. Following surgery post operatively the patients will be assessed for in hospital physical activity level in terms of step counts using the Mi bands worn from day 1 post surgery on the wrist till the day of discharge. During the time of discharge, Discharge evaluation of functional capacity in terms of 6minute walk test and presence of kinesiophobia using the Tampa Scale Kinesiophobia-Heart will be done. The patients will be followed up as a part of routine/standard of care at 30 days post-operatively and reassessment of quality of life using EQ-5D-5L questionnaire will be done

Following IEC approval and CTRI registration will be done and recruitment will be started after registration approval in CTRI.

 


 
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