| CTRI Number |
CTRI/2025/02/080512 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| 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
|
Effect of functional strength training versus Otago exercise on postural balance in fallers older adults. |
|
Scientific Title of Study
|
Comparison of functional strength training versus Otago exercise on postural balance in fallers older adults- A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Alkama |
| Designation |
Research Student |
| Affiliation |
Galgotias University |
| Address |
Room No E-005 Department Of Physiotherapy, School Of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh, 203201
India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
6299159330 |
| Fax |
|
| Email |
alkamam34@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sachin Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B228 Department Of Physiotherapy, School Of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh, 203201
India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr sachin Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B228 Department Of Physiotherapy, School Of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh, 203201
India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Developmental Cell, Galgotias University,India,203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No A315 Research and Development Cell,Plot NO 2 ,Sector 17-A Yamuna Expressway, Gautam Buddh Nagar, Greater Noida, Uttar Pradesh 203201
|
| Type of Sponsor |
Research institution |
|
|
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 MD ALKAMA |
Galgotias University |
Room No. E-003, Physiotherapy OPD, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh, 203201
India Gautam Buddha Nagar UTTAR PRADESH |
6299159330
alkamam34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University Departmental ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Geriatric Population Age 60-75 years.
2. Both Gender Male And Female |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Functional strenghth Training |
Intervention plan is 6 weeks
Chair rise
Forward reach to opposite foot
Forward walking
Side step walking
Combined forward and backward walking
Step up forward/down
Marching
Squatting
Forward and upward reach
Upper body rotation
|
| Intervention |
Otago Excercise |
Intervention plan is 6 weeks
Knee bends
Backwards walking
Walking and turning around
Sideways walking
Tandem stance
(heel-toe stand)
Tandem walk
(heel-toe walk)
One leg stand
Heel walking
Toe walking
Heel-toe walking backward
Sit to stand
Stair walking
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants will be recruited for the study if they will be able to walk without any assistive device up to a distance of 10 meters and able to sit to stand before enrollment.
2. Participants should
have sufficient cognitive ability to follow instructions and perform the exercises, as assessed by tools like the Mini-Mental State
Examination (MMSE)
3. MMSE score of 24 and above.
4. History of fall in previous 12 months. |
|
| ExclusionCriteria |
| Details |
1. Individuals with recent spine or lower limb injuries that limit movement or activity.
2. Individual who have recently had surgery.
3. Those with advanced osteoporosis, severe arthritis, or similar conditions that could worsen with activity.
4.People with neurological disorders that affect walking or balance,like multiple sclerosis, Parkinson’s disease, or stroke. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
1. Before Intervention At The Baseline.
2. After Intervention, at The End Of The Week Of
Intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time up And Go Test |
1. Before Intervention, At The Baseline.
2. After Completion Of Intervention, At The End
Of The Six Week |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
21/02/2025 |
| 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="0" Months="3" Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
For older adults, falls and fall-related injuries have continued to be the primary cause of morbidity and death for the past thirty years. One Global population aging means that access to evidence-based, affordable fall prevention programs must be sustained. Globally, falls are a significant public health concern for the elderly. Every year, about one-third of older individuals living in the community and half of those in institutions fall (6). Aging-related issues include prolonged reaction times, cognitive decline, impaired balance, weaker muscles, and medicine side effects that raise the chance of falls (7). However, older adults can increase their physical flexibility and ability to balance, as well as lessen their risk of suffering a fall injury, by appropriately participating in sports events that emphasize these skills (8). Fall prevention lifestyle, Tai Chi, yoga, Pilates, resistance training, the Otago Exercise Program (OEP), fitness exercises for older adults, multi-objective stepping exercise, and fall prevention lifestyle (9). Among them, OEP has been shown to successfully enhance older adults’ cognitive function, balance ability, lower limb muscle strength, and functional physical fitness (10), prevent older adults from falling (10), hasten the recovery of physical function, and cut costs (11). It not only successfully increases one’s capacity for balance, but also boosts one’s self-assurance in one’s ability to maintain balance after several falls and overcome mental health issues including fear and social isolation (12, 13). The capacity to keep the body’s center of mass projected within the bounds of the base of support—whether sitting, standing, or moving to find a new base of support when walking—is called balance (14). Balance issues have been linked to lower confidence in one’s ability to maintain balance and an increased fear of falling, which is one of the main causes of falls (15). The OEP of a series of exercises for strengthening the legs, retraining the balance, and preventing falls a series of exercises for enhancing balance in senior citizens, with gains noted in functional ability, performance, and balance an app with a balancing workout program that was created with the help of consumer design principles to guarantee an age-appropriate and user-friendly interface for senior citizens. To improve long-term adherence and activity uptake, behavioral change methods are included (16). Functional strength training (FST) is gaining popularity as a new kind of exercise for people with heart conditions, middle-aged adults, athletes, and the elderly (17). It has been shown to improve health, help people control their weight, and improve daily activity performance. FST simulates specific movements that call for balance, strength, flexibility, and coordination (17). Strength training improves muscle mass, improves motor unit recruitment, and speeds up the stimulation rate of motor units in older adults (18). There are numerous systemic advantages of ST, which include enhanced bone health, reduced risk of cancer and depression, and better sleep (19). A meta-analysis also shown that ST is just as effective as stretching for increasing range of motion (19). In addition to enhancing older individuals’ strength and muscular hypertrophy, ST also helps these groups’ muscle endurance, aerobic capacity, balance, power, and range of motion (19).
|