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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).

 
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