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CTRI Number  CTRI/2024/04/065853 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving movement and balance in seniors adults through functional strength training versus strength training 
Scientific Title of Study   Effect of functional strength training versus strength training on functional movement, balance and mobility in older adults- 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  Dr Abhimanu Tiwari 
Designation  Research Student 
Affiliation  Galgotias University 
Address  Room No E-005, Department of Physiotherapy, SAHS, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6009913726  
Fax    
Email  abhimanutiwariofficial@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Gupta 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, SAHS, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, Greater Noida, 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 B-319, Department of Physiotherapy, SAHS, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 203201 India


UTTAR PRADESH
203201
India 
Phone  9015193829  
Fax    
Email  sachinguptapt3@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University  
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No A315,Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International circuit, 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 Abhimanu Tiwari  Galgotias University  Plot No 2, Sector 17A, Opposite Gautam Buddha International Circuit, Yamuna expressway Gautam Buddha Nagar UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 		 6009913726

abhimanutiwariofficial@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethics Commitee, Galgotias Univerity  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  older adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional Strength Training Duration of protocol 6 weeks 6 days per week 40-45 minutes of duration per session  Table 1 FST intervention 1 week 2 week 3 week 4 week 5 week 6 week • Chair rise • Forward reach to opposite foot • Forward walking • Side step walking • Combined forward and backward walking At preferred speed (5 rep) • Same exercises of 1st week at fast speed • Step up forward/down • Marching • Squatting • Forward and upward reach • Upper body rotation At preferred speed (5rep) • Same exercises of 1st week at slow speed • Same exercises of 2nd week at fast speed (5rep) • Same exercises of 1st week with adding difficulty (such as adding weight of any object) • Same exercises of 2nd week at slow speed (7 rep) • Same exercises of 1st week at slow speed with difficulty • Same exercises of 2nd week with more difficulty (10rep) • Same exercises as 1st & 2nd week protocol with changing the environment (10 rep)  
Comparator Agent  Strength Training Duration of protocol 6 weeks 6 days per week 40-45 minutes of duration per session  ST intervention 1 week 2 week 3 week 4 week 5 week 6 week • Hip flexion exe • Hip flexion with external rotation • Ankle Dorsiflexion • Toe raise • Hip flexion (5 rep) •Hip flexion with horizontal adduction of opposite shoulder • Terminal knee extension • Knee flexion • Hip abduction • Shoulder protractors and retractors (5 rep) •Resisted hip extension • Resisted hip abduction and internal rotation • Resisted Plantar flexion • Resisted hip extension and adduction (5 rep) •Resisted hip abduction/extension with shoulder abduction/flexion • Resisted terminal knee extension • Resisted knee flexion • Resisted hip abduction (7 rep) •Hip flexion and resisted hip extension • Hip flexion with external rotation and resisted hip abduction and internal rotation • Ankle Dorsiflexion with resisted Plantar flexion • Toe raises • Hip flexion with resisted hip extension and abduction • Hip flexion and with horizontal adduction of opposite shoulder and resisted hip abduction/extension with shoulder abduction/flexion • Resisted terminal knee extensions • Resisted knee flexion • Shoulder protraction and resisted retraction (10 rep) •Forward walking Progress to stop Start walking •Sideways walking • Walking while turning head (10 rep)  
 
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. MMSE score of 24 and above.
 
 
ExclusionCriteria 
Details  1. Any history of trauma, fracture, or surgery like total knee replacement (TKR).
2. Deformities of the spine and lower limbs, such as flat foot, pes cavus, and genu varum.
3. Any neurological disorder—stroke, Parkinson’s, and traumatic brain injury (TBI).
4. Any orthopedic disorder involving lumbar spine, pelvis, and lower extremities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Functional Movement-Functional movement
screen
2. Balance-Berg Balance Scale
3. Mobility-TUG Test 		 At baseline, 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) 27/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 involves the functional movement, balance and mobility in older adults determining the difference between the effect of functional strength training versus strength training on functional movement, balance and mobility in older adults. With an increase in the number of older adult fall and injury cases due to functional movement deficiency. Functional strength training (FST) is emerging as a new training method for middle-adults and older adults to improve functional movement. Around 650,000 accidental or unintentional injury fatalities occur worldwide each year, with falls ranking as the second most common cause. Older persons are more prone to falls. 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. 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. Strength training improves muscle mass, improves motor unit recruitment, and speeds up the stimulation rate of motor units in older adults (over 60).  
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