| CTRI Number |
CTRI/2026/01/100746 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| 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
|
Combined exercise and brain training intervention for improving strength and memory in frail older adults |
|
Scientific Title of Study
|
Evaluating the Efficacy Of a Structured Intervention Program On Physical And Neurological Frailty In Older Adults: Integrating Motor And Cognitive Rehabilitation Through a Multidimensional Perspective. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivangi Singh |
| Designation |
Student |
| Affiliation |
Amity University |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303,INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
6392818618 |
| Fax |
|
| Email |
singhshivii1211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Sharma |
| Designation |
Professor |
| Affiliation |
Amity University |
| Address |
Reasearch Lab, Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8580883100 |
| Fax |
|
| Email |
ksharma8@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Sharma |
| Designation |
Professor |
| Affiliation |
Amity University |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201303, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8580883100 |
| Fax |
|
| Email |
ksharma8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shivangi Singh |
| Address |
Sector 125, noida , uttar pradesh 201313,India |
| 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 |
| Manju Vishvakarma |
Step in physiotherapy clinic |
G-155, sector 44, noida, up
Gautam Buddha Nagar
UTTAR PRADESH |
9773715506
Manju@stepinphysiotherapy.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC community |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Participants in the control group receive standard care consisting of general health education, routine advice on healthy aging, and unstructured low-intensity activities. No structured physical exercise program or formal cognitive training is provided during the study period. |
| Intervention |
Structured Physical and Cognitive Training Program |
A structured, supervised 6-week intervention program conducted three times per week, with each session lasting 60 minutes (total 18 sessions). The program integrates physical exercise training and cognitive rehabilitation. Physical training includes strength exercises, balance training, flexibility exercises, and functional walking activities. Cognitive training includes memory tasks, problem-solving activities, and dual-task exercises performed simultaneously with physical activities. Sessions are delivered in small groups under the supervision of a qualified physiotherapist. Vital signs are monitored before each session, and safety precautions are maintained throughout the intervention. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age sixty to seventy five years.
Both male and female.
Mild to moderate physical frailty based on Fried Frailty Phenotype score one to four.
Mild cognitive impairment with MoCA score nineteen to twenty five.
Able to walk independently.
No major medical events in the past three months.
Signed informed consent. |
|
| ExclusionCriteria |
| Details |
Uncontrolled chronic diseases such as severe cardiac conditions or severe arthritis.
Recent surgery or hospitalization within the last six weeks.
Contraindications to exercise.
Participation in another intervention study.
Advanced cognitive impairment or dementia. |
|
|
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 |
| Change in physical and neurological frailty measured by Fried Frailty Phenotype score and MoCA score |
Baseline and Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in mobility measured by Timed Up and Go test
Change in quality of life measured by SF Thirty Six questionnaire
Number of falls and doctor visits during the study period |
Baseline and week six
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/01/2026 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 aims to evaluate the effect of a structured six week physical and cognitive training program on physical and neurological frailty in older adults. The trial follows a randomized controlled design with one intervention group and one control group. The intervention includes supervised sessions three times per week that combine strength exercises, balance training, walking practice, memory tasks, problem solving tasks and dual task activities. The control group receives routine health advice and low intensity activity. The study will assess changes in physical frailty using the Fried Frailty Phenotype and changes in neurological frailty using the MoCA score. Secondary outcomes include mobility measured by the Timed Up and Go test, quality of life measured by the SF Thirty Six questionnaire and the number of falls and doctor visits. Assessments will be carried out at baseline and at the end of six weeks. The trial seeks to determine whether a combined physical and cognitive program can improve strength, mobility and cognitive function in older adults living in the community.
|