CTRI Number |
CTRI/2020/01/023013 [Registered on: 28/01/2020] Trial Registered Prospectively |
Last Modified On: |
02/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Preventive |
Study Design |
Other |
Public Title of Study
|
Efficacy of Multi-factorial intervention to prevent falls among older adults |
Scientific Title of Study
|
Fall related disability and fall prevention among older adults: A community-based study in Pune city |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Snehal Kulkarni |
Designation |
Doctoral Student |
Affiliation |
Interdisciplinary School of Health Sciences, Savitribai Phule Pune University |
Address |
Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University,
Ganeshkind, Pune Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University,
Ganeshkind, Pune Pune MAHARASHTRA 411007 India |
Phone |
9762527200 |
Fax |
|
Email |
sneh.kulk@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Aarti Nagarkar |
Designation |
Assistant Professor (Mentor Phd) |
Affiliation |
Interdisciplinary School of Health Sciences, Savitribai Phule Pune University |
Address |
Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University, Ganeshkind, Pune Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University, Ganeshkind, Pune Pune MAHARASHTRA 411007 India |
Phone |
|
Fax |
|
Email |
aarati@unipune.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Aarti Nagarkar |
Designation |
Director |
Affiliation |
Interdisciplinary School of Health Sciences, Savitribai Phule Pune University |
Address |
Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University,
Ganeshkind, Pune Department:Interdisciplinary School of Health Sciences, Room No-5.
University: Savitribai Phule Pune University,
Ganeshkind, Pune Pune MAHARASHTRA 411007 India |
Phone |
|
Fax |
|
Email |
aarati@unipune.ac.in |
|
Source of Monetary or Material Support
|
Department of Science and Technology (DST) under the Women Scientist Scheme-B(WOS-B) |
|
Primary Sponsor
|
Name |
Interdisciplinary School of Health Sciences Savitribai Phule Pune University |
Address |
Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Ganeshkhind,Pune |
Type of Sponsor |
Other [State Government Academic Institute] |
|
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 |
DrAarti Nagarkar |
Interdisciplinary School of Health Sciences |
Room no-5, School of Health Sciences, Savitribai Phule Pune Univeristy, Ganeshkhind Pune Pune MAHARASHTRA |
9822437743
aarati@unipune.ac.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Savitribai Phule Pune University |
Approved |
Institutional Ethics Committee, Savitribai Phule Pune University |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Fall prevention among older adults |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Multi-factorial Intervention |
The Multi-factorial Intervention will consist of 4 components
i. Home based exercise module- This module will consist of stretching, balance training, mobility and strengthening exercises which will be performed under supervision and will be given once a week for a duration of 16 weeks. Each session will be for 45-60 minutes. Balance and gait parameters will be assessed at the end of 16 weeks and 20 weeks post intervention.
ii.Online/tablet based exercises- This module will consist of stretching, mobility, balance and strengthening exercises where participants will be sent a video of the exercises. These exercises will be the same as taught during the home based exercise session.The participants are expected to perform these exercises at home till the next home based exercise session. The duration of the session will be 30-45 minutes each day. Balance and Gait parameters will be assessed at the end of 16 weeks and 20 weeks post intervention.
iii. Awareness- Awareness about how fall occurs, what changes take place during a fall and what steps to take to avoid falls will be provided through education material.
iv. Counselling about home modification- Lastly, the intervention will consists of counselling regarding home modification to prevent falls. Here the knowledge of the participants regarding home modification will be assessed in pre-post manner, i.e before and after counselling. |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
74.00 Year(s) |
Gender |
Both |
Details |
Community dwelling older adults above 60 years of age.
Older adults who are categorized as at risk of falling as per balance and gait measurement.
Older adults who give consent to participate
|
|
ExclusionCriteria |
Details |
Older adults with presence of cognitive decline.
Older adults with known health conditions such as arthritis, osteoporosis, knee or hip prostheses, cardiovascular diseases, stroke.
Older adults with known upper or lower limb disability.
Older adults with any other known chronic illnesses which restrict participation. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in spatio-temporal gait parameters measured at 8 weeks and 16 weeks.
Improvement in balance measured at 8 weeks and 16 weeks.
Improved knowledge about home modification to prevent falls measured in pre-post manner
|
Balance and gait parameters will be assessed at 8 weeks (immediately after intervention) and 16 weeks post intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
NA |
|
Target Sample Size
Modification(s)
|
Total Sample Size="93" Sample Size from India="93"
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/02/2020 |
Date of Study Completion (India) |
16/08/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Most of the falls in older adults are associated with one or more identifiable risk factors such as weakness, poor vision, unsteady gait and balance, confusion, certain medications and environmental risk factors such as slippery floor, uneven roads, poor lighting etc. Falls among older adults often leads to decreased independence, inability to perform daily activities, psychological stress, hospitalization and disability. Review of the literature shows that many strategies to reduce the risk of falls have already been implemented among the elderly. The majority of these intervention strategies used a variety of approaches including medication management, vision correction, home modification and exercise including strength training and, balance training. Though these strategies have shown to be effective at reducing falls, they have not been conducted among the community dwelling older adults in India. Thus, there is paucity of community-based intervention programme for fall prevention in India. Evidence suggests that interventions targeting fall risk factors are effective. As falls in older adults are not recognized in India, it remains unknown whether, or to what extent, this body of evidence has been effective in Indian community dwelling older adults. Therefore, the current quasi-experimental study aims to study the efficacy of a multifactorial intervention in the prevention of fall. The intervention will be divided into 4 quadrants: 1) Monitored exercise module 2) Home-based exercise module 3) Awareness-Education material 4) Counselling about home modification. The intervention will consist of monitored home based exercise program and online/tablet based exercise programme which will help in improving the balance and gait parameters. Balance and gait will be measured at the beginning of the study, and then measured again at the end of the intervention at 16 weeks and 20 weeks post intervention. The third and the fourth component will be addressed through providing educational material and counselling about home modification such as using grab bars, lights in the corridors, anti-slippery flooring etc. Knowledge regarding falls and home modification will be assessed before and after the intervention. This research would be helpful in creating sufficient evidence for recognizing fall in older adults as a public health issue and need to address it in the public health system. |