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CTRI Number  CTRI/2020/04/024722 [Registered on: 20/04/2020] Trial Registered Prospectively
Last Modified On: 10/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Muscle function and how it affects function in heart failure 
Scientific Title of Study   Prevalence of sarcopenia and its association with function and mobility in acute decompensated heart failure 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lakshman Iyer 
Designation  Post graduate student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9930849135  
Fax    
Email  krishiyer1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abraham Samuel Babu 
Designation  Associate Professor, Department of Physiotherapy, MCHP, MAHE 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9742502838  
Fax    
Email  abraham.babu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali K 
Designation  Professor and Head, Department of Physiotherapy, MCHP, MAHE 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8296011839  
Fax    
Email  vaishali.kh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India 
 
Primary Sponsor  
Name  Lakshman Iyer 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India 
Type of Sponsor  Other [Self] 
 
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 
Mr Lakshman Iyer  Department of Physiotherapy & Department of Cardiology, Kasturba Hospital  Madhav Nagar, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA 		 9930849135

krishiyer1996@gmail.com 
 
Details of Ethics Committee  
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: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ADHF in-patients ( Framingham criteria )
Diagnosed HF ( >1 year )
Age – no limit
New York Heart Association (NYHA) class II – IV
Corrected vision / normal vision
Functionally ambulant 
 
ExclusionCriteria 
Details  Soft tissue injury in the past 1-3 months
Fracture in lower extremities in the past 3-6 months
Neurological conditions causing significant impairments like stroke
Medically unstable patients (acute MI)
Any medical disorder which precludes participation
Short Blessed Test score > 7 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SARCOPENIA
Using the European Working Group on Sarcopenia in Older People (EWGSOP2) Algorithm consisting of
1. Short Physical Performance Battery
2. Timed Up and Go test
3. SARC-F questionnaire
4. Bioelectrical Impedance Analysis
 		 On the date of discharge
 
 
Secondary Outcome  
Outcome  TimePoints 
1.6 Minute Walk Test
2.Mobility Disability Scale
3.Fried Frailty Index
 		 On the date of discharge
 
1.Major Adverse Cardiovascular Events
2.Mobility Disability Scale 		 1,3 and 6 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   20/04/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This a cross sectional study to investigate the prevalence of Sarcopenia and it’s association with function and mobility in Acute Decompensated Heart Failure.

AIM:

To determine prevalence of sarcopenia and impact of acute decompensated heart failure on function and mobility

 

OBJECTIVES:

1) Assess the prevalence of sarcopenia in individuals with acute decompensated heart failure

2) Assess the association of sarcopenia with function and mobility in individuals with acute decompensated heart failure

3) To determine outcomes (MACE & Mobility disability) at 1, 3 and 6 months post discharge

 

PROCEDURE:

110 participants with ADHF will be included in the study based on screening done for inclusion and exclusion criteria. Informed consent will be taken from every participant prior to collection of data. Outcome measures will be assessed once patient is stable. Participants will be explained the procedure prior to performance, and standard guidelines will be followed at all times.

The European Working Group on Sarcopenia in Older People 2 (EWGSOP2) algorithm will be administered as follows:

·         Starting with screening for sarcopenia using the SARC-F questionnaire

·         Once screening is completed, the next step is assessment of muscle strength. This is either done by Chair stand test or by Handgrip strength assessment.

·         Confirmation of sarcopenia is done with the help of muscle quantity estimation. Bioelectrical Impedance Analysis (BIA) is used to estimate the total or appendicular skeletal muscle mass (ASM).

·         This confirmatory test is followed by assessing the severity of sarcopenia with performance tests including Short Physical Performance Battery (SPPB) as well as the Timed Up and Go test (TUG).

This will be followed by bedside administration of Mobility Disability Scale (MDS). Frailty will be assessed with FRIED Frailty index. 6 Minute Walk Test will be performed to assess function. 

The participants will be followed up at 1, 3 and 6 months to collect information regarding any Major Adverse Cardiovascular Events (MACE) and mobility disability via MDS.

 
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