Effect of Multi-condition on Mobility-Disability after Cardiac Device Implantation
- Conditions
- 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,
- Registration Number
- CTRI/2023/08/056561
- Lead Sponsor
- Miss Mrunal Dhore
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 81
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mobility-Disability Scale at postoperative day one | at 1 month
- Secondary Outcome Measures
Name Time Method Charlson Comorbidity Index of multimorbidity at admission Six Minute Walk Test for functional capacity at admission at discharge Mi bands for physical activity from post operative day one to day of discharge Tampa Scale Kinesiophobia Heart at admission at discharge EQ 5D 5L for quality of life at discharge MACE at 1 month follow up
Trial Locations
- Locations (1)
Kasturba Hospital Manipal
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital Manipal🇮🇳Udupi, KARNATAKA, IndiaMiss Mrunal DhorePrincipal investigator7020514037dhoremrunal06@gmail.com