| CTRI Number |
CTRI/2023/12/060793 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Dual-Task Training on Executive Functions in Older Adults |
|
Scientific Title of Study
|
Comparison on Effectiveness of Sequential and Simultaneous Dual-Task Training on executive functions and balance in older adults: 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 |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room Number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room Number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anjum Samnani |
| Designation |
Postgraduate Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
8871638318 |
| Fax |
|
| Email |
anjumsamnani7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi - 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi - 110025 |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Dr Majumi M Noohu |
OPD, Centre for Physiotherapy and Rehabilitation Sciences Clinic, Jamia Millia Islamia, New Delhi |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi - 110025
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Institutional Ethical Committee, Jamia Millia Islamia, Jamia Nagar, New Delhi - 110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Older Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sequential Dual-Task Training |
Sequential group will receive, balance intervention followed by cognitive training. Exercise will be given for 8 week; 3 sessions per week (total 24 sessions) under the supervision. Each session will last for 40-60 mins, beginning with 10 mins warm-up and 5mins cool down. |
| Comparator Agent |
Simultaneous Dual-Task Training |
Simultaneous group will receive balance and cognitive training simultaneously. Exercise will be given 3 sessions per week for 8 weeks (total 24 sessions) under the supervision. Each session will last for 40-60 mins, beginning with 10 mins warm-up and 5mins cool down. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age > 60 years of all genders
Able to walk independently without assistive device
Montreal Cognitive Assessment Scale score > 21
Subjects with minimum to no risk of falls according to Short-FES (cut off score of 7-8 out of 28)
Subjects upto moderate osteoarthritis (grade-3) according to Kellgren and Lawrence, 1957
Individuals with basic knowledge of primary education
Able to understand simple instructions and sign an informed consent form
|
|
| ExclusionCriteria |
| Details |
Individuals with neurological and psychological disorders
History of surgery in lower limb within past 6 months prior to trial
Individuals with auditory or visual impairments
Individuals on pharmacological treatment modifying psychological and psychiatric functions
Individuals participating in any other trial
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. P300 records an Event-Related Potential and is used to analyze brain waveforms that corresponds to attention memory and information processing.
2. Trail Making Test (TMT-A and TMT-B) used to assess executive function and attentional abilities. Part A of TMT evaluates the information processing speed, while part B assesses cognitive flexibility or switching. In part A, the task consisted in connecting numbers (from 1 to 25) with straight lines as fast as possible. In part B, participants had to alternate between letters in alphabetical order and numbers in ascending order (1-A-2-B-3C, etc.) as fast as possible.
3. The Stroop Test assesses selective attention and inhibition. |
Baseline Assessment at 1st week before the commencement of trial.
At 8th week post-intervention assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. One Leg Standing Test (OLST) evaluates static balance.
2. Timed Up & Go (TUG) evaluates dynamic balance and mobility.
3. 10 Meter walk test (10MWT) used to assess gait speed.
4. 10 meter walk test dual- task (10MWT-DT) to assess gait speed while counting in threes from 100. |
Baseline Assessment at 1st week before the commencement of trial.
At 8th week post-intervention assessment. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background and Aims - Sequential Dual Task-Training is as effective as Simultaneous Dual-Task Training in improving balance and gait speed. Therefore this study aims to compare the effectiveness of sequential and simultaneous dual-training on executive training to reverse or delay the cognitive decline associated with aging.
Methodology - It will be a prospective randomized controlled trial, including healthy older adults (60 years of age and above, both males and females, having primary level of education). The participants will be screened for mild cognitive impairment and risk of fall using Montreal Cognitive Assessment Scale (MoCA) and Short - Falls Efficacy Scale (Short- FES) respectively. 46 older adults will be randomly assigned to two groups - group 1 (SEQ-G) receiving balance exercise followed by cognitive training, group 2 (SIM-G) receiving balance exercise and cognitive training simultaneously under supervision.
Results - will be reported for all the outcome measures at baseline and post-intervention at the 8th week. Statistical analysis using SPSS software to compare the changes between the two groups and changes within the groups using 2X2 ANOVA.
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