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CTRI Number  CTRI/2026/01/100466 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effects of Stronger and Gentle Exercise on Thinking Ability, Balance, and Physical Function in Older Adults with Memory Problems.  
Scientific Title of Study   Effect of High-Intensity Functional Training in comparison with Low-Intensity Functional Training on Cognition, Balance, and Functional Ability in Older Adults with Cognitive Impairment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gagan Deep Singh 
Designation  PhD Scholar 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9896918644  
Fax    
Email  drgagan150@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akanksha Saxena 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9958729161  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr Akanksha Saxena 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9958729161  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Source of Monetary or Material Support  
I will myself bear theother cost required. Address_ Gagan Deep Singh (PhD Scholar), Room no.-1, TDTR DAV Institute of Physiotherapy and Rehabilitation, yamunanagar, Haryana, Pincode-135001 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 
Gagan Deep Singh  T.D.T.R. D.A.V. Institute of Physiotherapy and Rehabilitation  Room no.1 Department of Neurology, T.D.T.R. D.A.V. Institute of Physiotherapy and Rehabilitation
Yamunanagar
HARYANA 		 9896918644

drgagan150@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High-Intensity Functional Training  High-intensity functional training program consisiting of multi joint functional exercise at high intensity. Training includes muscle strength, balance and functional mobility exercises tailored to older adults with cognitive imapirement. with a total duration of 8 weeks, comprising three sessions per week, each lasting 45 minutes. 
Comparator Agent  Low-intensity functional training  Low-intensity functional training program involving basic functional exercises performed at low intensity. Exercises focus on mobility, balance and daily functional activities with minimal physical exertion.with a total duration of 8 weeks, comprising three sessions per week, each lasting 45 minutes. 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Montreal Cognitive Assessment (MoCA) score of 18 to 25 points (mild to moderate cognitive impairment).
2.Able to stand and walk independently (with or without an assistive device), and perform sit-to-stand independently.
3.Able to safely participate in moderate to high-intensity physical activity, as confirmed by Borg RPE score equal to or less than 13 after a six- minute walk or functional trial
4.Resting BP less than 160/100mmHg..
5.Not currently participating in a structured exercise program (minimum 4 weeks prior)
6.Demonstrates ability to follow simple one to two step verbal instruction during screening
7.Willing to provide informed written consent.
 
 
ExclusionCriteria 
Details  1.Diagnosis of moderate to severe dementia, history of stroke or other neurodegenerative condition.
2.History of psychiatric disorders requiring hospitalization.
3.Uncontrolled cardiovascular conditions
4.Resting blood pressure greater than 160/100 mmHg.
5.Severe musculoskeletal disorders limiting mobility (e.g., recent fracture, severe osteoarthritis, or joint replacement etc in past 6 months).
6.Uncorrectable visual or auditory impairments that hinder safe participation in exercise
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale,
MoCA Score,
functional Independence Measure 		 Pre test data, at the end of 4th week and post test data at the end of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size
Modification(s)  		 Total Sample Size="28"
Sample Size from India="28" 
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   Phase 1 
Date of First Enrollment (India)   21/01/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 proposed study aims to examine the effect of High-Intensity Functional Training (HIFT) compared with Low-Intensity Functional Training (LIFT) on cognition, balance, and functional ability in older adults with cognitive impairment. As cognitive decline is often accompanied by reduced mobility and balance, identifying effective exercise strategies is essential for improving overall quality of life in this population. Participants will be assigned to either a HIFT or LIFT program, with both interventions focusing on functional, task-oriented movements relevant to daily activities. Outcome measures related to cognitive performance, postural balance, and functional mobility will be assessed before and after the intervention period. The findings of this study are expected to provide evidence on whether higher-intensity functional training offers superior benefits compared to low-intensity training in older adults with cognitive impairment, thereby guiding future rehabilitation and exercise prescription practices. 
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