| CTRI Number |
CTRI/2024/10/075186 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research study on the importance of balance and neurobic exercise on reducing falls in senior citizens. |
|
Scientific Title of Study
|
Effect of balance and neurobic exercise on fall prevention in elderly population: An Experimental 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 |
Sah Priya Sanjay |
| Designation |
Master of Physiotherapy (Neurological Sciences) |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Narayana Health City, Department of Physiotherapy, room no 19, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099
258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA
560099
India |
| Phone |
8160454964 |
| Fax |
|
| Email |
priyasah3008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajendra Kachhwaha |
| Designation |
Principal |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099.
258/A, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9529822777 |
| Fax |
|
| Email |
rajendra.kachhwaha@hrudayalayafoundation.org |
|
Details of Contact Person
Public Query
|
| Name |
Sah Priya Sanjay |
| Designation |
Master of Physiotherapy (Neurological Sciences) |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099
258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA
560099
India |
| Phone |
8160454964 |
| Fax |
|
| Email |
priyasah3008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya Foundations
258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore, 560099
India |
|
|
Primary Sponsor
|
| Name |
Sah Priya Sanjay |
| Address |
258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Sah Priya Sanjay |
Narayana Hrudayalaya hospital, old age home |
258/A, Narayana Health city, Department of Physiotherapy, room no. 19 Bommasandra, Industrial area, Anekal Taluk, Bangalore-5600
Bangalore
KARNATAKA |
8160454964
priyasah3008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Hrudayalaya Academic Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Balance and mild cognition impairment in elderly population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (balance exercise) |
Balance exercise: Warm-up exercises include Head and neck movement, back extension, trunk movement, ankle movement (each 10 rep). Strengthening exercises include front and back knee strengthening, side hip strengthening, calf raise, toe raise (each 10 rep).
Following are the balance exercises:
Knee bends (10 repetitions), Backward walking (10 steps, 4 times),Walking and turning (twice),Sideways walking (10 steps,4 times),Heel-toe stand (10 seconds),One-leg stand (10 seconds), Heel walking (10 steps, 4 times),Toe walking (10 steps, 4 times),Sit-to-stand (5–10 stands), Stair walking (as tolerated) |
| Intervention |
Experimental group (balance exercise with neurobic exercise) |
Balance exercise: Warm-up exercises include Head and neck movement, back extension, trunk movement, ankle movement (each 10 rep). Strengthening exercises include front and back knee strengthening, side hip strengthening, calf raise, toe raise (each 10 rep).
Following are the balance exercises:
Knee bends (10 repetitions), Backward walking (10 steps, 4 times),Walking and turning (twice),Sideways walking (10 steps,4 times),Heel-toe stand (10 seconds),One-leg stand (10 seconds), Heel walking (10 steps, 4 times),Toe walking (10 steps, 4 times),Sit-to-stand (5–10 stands), Stair walking (as tolerated)
Neurobic exercise: Using 6 senses such as seeing, hearing, tasting, smelling, touching and emotional sense in combining two, listening and smelling, touching and seeing or smelling, seeing and tasting as well as playing card, digits recall, calculating in mind, asking time and place, phrase repetition and identifying photos.
Stimulation of visual sense through tray game, Stimulation of hearing sense through listening and identifying nature sounds, Stimulation of tasting sense through tasting fruit and food, Stimulation of smelling sense through natural aroma, Stimulation of touching sense through identifying objects, Stimulation of emotional sense
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group 60 or above
2)Able to provide written consent form
3)Mild to moderate balance dysfunction (BBS score 40-56)
4)Ability to communicate and understand communication.
5)No depressive symptoms.
6)Not involved in any other type of exercise.
7)Willing to participate in the experiment.
|
|
| ExclusionCriteria |
| Details |
1) Moderate to Severe Cognition impairment (MoCA score ≤ 17)
2) Neurological and musculoskeletal disorders that unable to complete the planned exercise program.
3) Hearing and visual impairment as diagnosed by physician
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fall Efficacy Scale-International |
After the 6 week of application of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
After the 6 week of application of intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/10/2024 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
This study is an experimental to find out effect of balance and neurobic on fall prevention in elderly population. Null Hypothesis: There
will be no significant effect of balance and neurobic exercise on fall prevention
in elderly population. Alternative Hypothesis: There will be significant effect
of balance and neurobic exercise on fall prevention in elderly population OBJECTIVE OF STUDY · To compare the effect of balance with neurobic exercise
and balance exercise on fall prevention in elderly population. · To evaluate the effect of the balance exercise on fall
prevention in elderly population.
· To evaluate the effect of the neurobic exercise on fall prevention
in elderly population. |