| CTRI Number |
CTRI/2018/10/016237 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
31/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Nutraceutical
Other (Specify) [computer based cognitive exercise] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effect of diet, exercise and technology in memory impaired elderly |
|
Scientific Title of Study
|
Effect of multimodal intervention (diet, exercise and computer based cognitive training) amongst elderly subject with subjective cognitive impairment (SCI) from Delhi and NCR- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashun Chatterjee |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITITE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
Room No. 7, Dept. of Geriatric Medicine, New Private Ward, AIIMS
South
DELHI
110029
India |
| Phone |
9013632920 |
| Fax |
|
| Email |
drprasun.geriatrics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashun Chatterjee |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITITE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
Room No. 7,Dept. of Geriatric Medicine, New Private Ward, AIIMS
South
DELHI
110029
India |
| Phone |
9013632920 |
| Fax |
|
| Email |
drprasun.geriatrics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashun Chatterjee |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITITE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
Room No. 7, Dept. of Geriatric Medicine, New Private Ward, AIIMS
South
DELHI
110029
India |
| Phone |
9013632920 |
| Fax |
|
| Email |
drprasun.geriatrics@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi–110016
Tel: 011-26590339, Telefax: 011-26964793
|
|
|
Primary Sponsor
|
| Name |
DST Tide |
| Address |
Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi–110016
Tel: 011-26590339, Telefax: 011-26964793
|
| Type of Sponsor |
Government funding agency |
|
|
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 Prashun Chatterjee |
All India Institute of Medical Sciences, Delhi |
Room no. 7, Dept. of Geriatric Medicine, New Private Ward
South
DELHI |
9013632920
drprasun.geriatrics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjective cognitive impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
First |
Health Awareness through IEC Material |
| Intervention |
Fourth Arm |
Computer based cognitive training using RehaCom Software focusing on Attention, Memory, Executive Functioning and Visuospatial abilities thrice in a week for 4 months + Diet will include counselling to consume Indianised version of Meditteranean diet for 6 months |
| Intervention |
Second Arm |
Diet will include counselling to consume Indianised version of Meditteranean diet for 6 months + PHYSICAL THERAPY including both aerobic and resistance exercises thrice in a week for 6 months + Computer based cognitive training using RehaCom Software focusing on Attention, Memory, Executive Functioning and Visuospatial abilities thrice in a week for 4 months |
| Intervention |
Third Arm |
Computer Based Cognitive Training using RehaCom Software focusing on Attention, Memory, Executive Functioning and Visuospatial abilities thrice in a week for 4 months |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient attending Geriatric medicine memory clinic with SCI but no dementia with intact ADL & IADL |
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of MCI and dementia;
2. Moderate Depression(10-19).
3. Impaired ADL & or IADL.
4. Severe Obstructive pulmonary disease (FEV1<30%)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in cognitive performance by Stroop color and word test, Wisconsin card sorting test and PGI Memory Scale score. |
6 months, 1 year and 2 years . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in score of functionality and quality of life by ADL, IADL and SF36. |
12 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
08/11/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Similar study has not been done and will be published after the completion of work |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
subjective cognitive impairment (SCI) is characterised by subjective deficit in capacities including remembering names and recalling where one has placed things, but psychometrically and mental status test scores are within the normal range. Studies suggest nutrition has profound implications for cognitive decline and dementia mediated by changes in expression of multiple genes. Exercise benefits executive control process of cognition including selective attention, planning, organizing, multitasking,inhibition, and working memory. similarly cognitive training has been found to be an effacious approach that targets specific cognitive domains in order to maintain or improve their function. We propose multimodal intervention ( diet, exercise and computer based training) in individuals with SCI which can be a non pharmacological effective way of prevention of cognitive impairment. |