| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rejianilp@gmail.com].
- 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.
- 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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