FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067019 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Fall prevention in Old Age 
Scientific Title of Study   A population based, cohort study for risk reduction of “fall” in elderly :An interprofessional approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snigdha 
Designation  Professor and Head of Department  
Affiliation  Apollo institute of medical science and research 
Address  Apollo institute of medical science and research, Apollo Health Street, Jubile Hills ,HYDERABAD
d5,Doctors quarters, Indo American Cancer Hospital, Banjara Hills,Road no 14, Hyderabad -500034
Hyderabad
TELANGANA
500096
India 
Phone  9912766229  
Fax    
Email  snighda_patnaik@apolloimsr.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Snigdha 
Designation  Professor and Head of Department  
Affiliation  Apollo institute of medical science and research 
Address  Apollo institute of medical science and research, Jubilee hills ,Hyderabad
D5,Doctors quarters, Indo American Cancer Hospital, Road no 14, Hyderabad,500034
Hyderabad
TELANGANA
500096
India 
Phone  09912766229  
Fax    
Email  snighda_patnaik@apolloimsr.edu.in  
 
Details of Contact Person
Public Query  
Name  Snigdha Pattnaik  
Designation  Professor and Head of Department  
Affiliation  Apollo institute of medical science and research 
Address  Apollo institute of medical science and research, Jubilee Hills, Hyderabad
D5,Doctors quarters, Indo American Cancer Hospital, Road no 14, Banjara Hills, 500034
Hyderabad
TELANGANA
500096
India 
Phone  9912766229  
Fax    
Email  snighda_patnaik@apolloimsr.edu.in  
 
Source of Monetary or Material Support  
Apollo Institue of Medial Sciences and Research,Hyderabad. 
Apollo Institute of Medical Sciences And Research,Jubilee Hills,hYDERABAD,Pin-500096 
 
Primary Sponsor  
Name  Dr Snigdha Pattnaik 
Address  Apollo Institute of Medical Science and Research,Jubillee hills ,Hyderabad,Pin-500096 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Snigdha Pattnaik  Apollo Institute of Medical Sciences ,Hyderabad.  Department of Community Medicine, Professor and HOD rOOM,fIRST FLOOR,Apollo Medical College administration Building.
Hyderabad
TELANGANA 		 9912766229

snighda_patnaik@apolloimsr.edu.in 
Snigdha Pattnaik  Shekpet  Apollo institute of medical science and research
Hyderabad
TELANGANA 		 9912766229

snighda_patnaik@apolloimsr.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIMSR,Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Person in study age group(60-75 years), who are vulnerable to fall. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  All older people over 60 years ,at increased risk of falling will be considered for an individualised multifactorial intervention. 1.Strength and balance training .   2 Home hazard assessment and intervention. 3 Vision assessment and referral to the nearby community medicine health center. 4 Medication review with modification/withdrawal Duration of intervention : 3 months (12 WEEK) 
Comparator Agent  Not Applicable   Not Applicable 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  People who are likely to fall and sustain injury. 
 
ExclusionCriteria 
Details  Not giving consent.
already sustained fall. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevent fall in 60 years above age group.
 		 After 3 months of Intervention of Balance Training,Eye check up,Medical Review ,Home enviroment assessment and other associated illness(if any)
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of participants leading a better quality of life.  1 and half months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snighda_patnaik@apolloimsr.edu.in].

  6. For how long will this data be available start date provided 30-07-2024 and end date provided 11-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Above 60 years population in study area will be enrolled.Risk reduction of Fall will be done by 1.1inspecting the housing enviroment.2.Muscle training.3.Psychological councelling.4.Medication review. 
Close