| CTRI Number |
CTRI/2025/06/088835 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Physical activity level on Physical Performance and history of falls among Elderly individual. |
|
Scientific Title of Study
|
Impact of Physical Activity level on Functional capacity and Falls
among Elderly individual: A Cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini Soni |
| Designation |
1st year MPT (Community Physiotherapy) |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9404926601 |
| Fax |
|
| Email |
nandinisoni02official@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8554990224 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India
MAHARASHTRA
414111
India |
| Phone |
8554990224 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFS COLLEGE OF PHYSIOTHERAPY opposite government milk dairy MIDC Vilad Ghat Ahmednagar Maharashtra 414111 |
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednagar |
| Address |
DVVPFS college of Physiotherapy opposite government milk dairy MIDC Vilad Ghat Ahmednagar Maharashtra 414111 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Nandini Soni |
DVVPFS College of Physiotherapy |
Department of Community Physiotherapy block
one basement DVVPFS
College of Physiotherapy
Ahmednagar 414111
Ahmadnagar
MAHARASHTRA |
9404926601
nandinisoni02official@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committee Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
individuals with history of falls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
fall history in past one year
MMSE score |
|
| ExclusionCriteria |
| Details |
Neurological disease
Musculoskeletal problems that limit their participation e.g. Lower limb fractures, hip
replacement surgery.
Unstable and severe health conditions
Mobility deficits that prevent the older adults from moving in the orthostatic position
independently.
Cognitive impairment that prevents the participant from understanding the
assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
International Physical activity questionnaire
short physical performance battery protocol |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
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)
|
21/07/2025 |
| 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)
|
Open to Recruitment |
| 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 - NO
|
|
Brief Summary
|
One of the most dangerous health issues that older adults confront is falls. Efforts must be undertaken to identify those who are at risk of falling
and to avoid or lessen the frequency of falls in order to lower the concerning rates of falls and
excessive mortality and morbidity. Understanding the causes of falls in the elderly and the risk
factors for falls is crucial to enabling such strategies. Maintaining physical function and mobility through
physical activity (PA) can postpone the onset of significant impairment. The most often
evaluated fall prevention strategy is PA alone. In terms of physical capacity, senescence is characterized by a decline in muscle mass, strength,
flexibility, mobility, and physical performance. Age-related declines in functional capacity and
exercise tolerance can also be linked to chronic diseases, decreased protein synthesis, and
physical inactivity, which can result in functional restrictions that raise the risk of disability and
death. In this sense, the subject’s degree of physical performance is a crucial factor in the context
of geriatric clinical evaluation. This study aims to evaluate the relationship between physical activity and functional
performance and falls in elderly individuals, providing insights that can guide the development
or improvement of strategies to reduce falls and enhance overall mobility and safety in this
population. |