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CTRI Number  CTRI/2026/02/103992 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 13/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Among older adults with cognitive frailty whether there is a significant difference in the postintervention effects of exercises with cognitive and motor components, multi component physical exercises alone and standard care on fall Risk and functional capacity after twelve weeks of training.  
Scientific Title of Study   Effects of cognitive motor dual task and multimodal exercises on fall risk, intrinsic capacity and quality of life in older adults with cognitive frailty 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  Rejimol Jos Pulicken 
Designation  Associate Professor 
Affiliation  LIttle Flower Institute Of Medical Sciences And Research ,Angamaly 
Address  Rejimol Jos Pulicken, Associate professor, Physiotherapy Department Limsar, Angamaly

Ernakulam
KERALA
683572
India 
Phone  9495220118  
Fax    
Email  rejianilp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr J K Mukkadan 
Designation  Research director 
Affiliation  Little flower institute of medical sciences and research, Angamaly 
Address  Little f lower hospital and research center, Angamaly

Ernakulam
KERALA
683572
India 
Phone  9387518037  
Fax    
Email  drmukkadan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rejimol Jos Pulicken 
Designation  Associate Professor 
Affiliation  LIttle Flower Institute Of Medical Sciences And Research ,Angamaly 
Address  Rejimol Jos Pulicken, Associate professor, Physiotherapy Department Limsar, Angamaly


KERALA
683572
India 
Phone  9495220118  
Fax    
Email  rejianilp@gmail.com  
 
Source of Monetary or Material Support  
Little Flower Hospital And Research Center 
 
Primary Sponsor  
Name  Rejimol Jos Pulicken 
Address  Associate Professor Limsar Angamaly 683572 
Type of Sponsor  Other [Self] 
 
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 
DrRejimol Jos Pulicken  Little Flower Institute Of Medical sciences And Research   Department Of Physiotherapy Rehabilitation Division 7th Floor St Alphonsa Block L F Hospital Angamaly,683572
Ernakulam
KERALA 
9495220118

rejianilp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Little Flower Hospital And Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R54||Age-related physical debility, (2) ICD-10 Condition: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive motor dual task exercises  Physical exercises along with cognitive training sessions given simultaneously and sequentially three times a week for 12 weeks 
Comparator Agent  Educational sessions along with usual activities  This group receives health education on aging, nutrition, and social engagement and advised to continue their usual activity level for 12 weeks 
Intervention  multimodal Exercises  Structured multicomponent supervised physical exercises including flexibility resistance balance and cardiac training given 3 times a week for 12 weeks 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Participants with physical frailty, mild cognitive impairment and functional independence. 
 
ExclusionCriteria 
Details  Participants with dementia, severe cognitive impairment, severe depression, degenerative diseases of nervous system , vision and hearing impairment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fall risk measured by Timed Up and Go  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
intrinsic capacity  12 weeks 
Quality of life  12 weeks 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   27/02/2026 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rejianilp@gmail.com].

  6. For how long will this data be available start date provided 31-01-2028 and end date provided 31-01-2038?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Title of the Study Effects of Cognitive Motor Dual Task and Multimodal Exercise on Fall Risk Intrinsic Capacity and Quality of Life in Older Adults with Cognitive Frailty A Randomized Controlled Trial 
Background Population aging in India is increasing the prevalence of functional limitations. Cognitive Frailty is a high risk geriatric syndrome characterized by the coexistence of physical frailty and cognitive impairment excluding dementia. It is a significant predictor of future falls. Intrinsic Capacity is an integrative measure of physiologic reserve across locomotion vitality cognition psychological and sensory domains. Evidence suggests that cognitive motor dual task training and multimodal exercises may improve functional capacity and reduce fall risk in this population.
Objectives The primary objective is to compare the effects of cognitive motor dual task training multimodal exercise and standard care on fall risk. Secondary objectives include comparing post intervention effects on the Intrinsic capacity composite score and overall quality of life among the three groups.
Methodology This is a three arm parallel group assessor blinded randomized controlled trial conducted in selected elderly homes in central Kerala. Participants aged 65 and above with cognitive frailty will be recruited and randomized into three groups using block randomization. The sample size is 126 participants with 42 per group. The intervention groups will receive either dual task training or multimodal exercises for twelve weeks three days per week for 50 minutes per session. Standard care includes health education. 
Cognitive Motor Dual Task program focuses on performing cognitive tasks while simultaneously or sequentially performing motor training. Individualized 20-minute sessions focus on dual-task progression, while 30-minute group sessions involve functional circuits, resistance training, or dance. Cognitive stimuli include tasks involving speech, memory, arithmetic thinking, and attention. Complexity increases from sequential to simultaneous tasks based on participant achievement.
Multimodal Exercise Participants receive a supervised 12-week intervention comprising resistance, balance, cardiovascular, and flexibility exercises 3 times per week. Each 45 to 50-minute session includes individual and group-based training. Resistance training involves 3 sets of 12 repetitions using weights or resistance bands, while cardiovascular training consists of walking bouts. Balance training includes static and dynamic exercises such as walking on heels or toes. Flexibility training involves arm stretches held for 12 seconds. Intensity is tailored to each participant Rate of Perceived Exertion using the Borg Scale
 Control Group receives health education on aging, nutrition, and social engagement and is advised to continue only their usual activity levels.
Primary outcome measures is Timed Up and Go for fall risk. Secondary outcomes intrinsic capacity will be calculated based on domain scores of Short Physical Performance Battery for locomotion hand grip for vitality MoCA for cognition GDS for depression. Quality of life is assessed using SF 12.
Expected Outcome Post intervention measures are taken at the end of 12 weeks. It is hypothesized that there will be a significant difference in post intervention effects between the three groups specifically that targeted exercise interventions will reduce fall risk and optimize intrinsic capacity and quality of life in cognitively frail older adults.

 
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