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
|
|
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
|
|
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
|
|
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
|
|
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. |