| CTRI Number |
CTRI/2021/03/031965 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Brain Exercises for better memory |
|
Scientific Title of Study
|
Brain Exercises for better cognitive functioning |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dheeraj Khurana |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Neurology, PGIMER, Chandigarh
Department of Neurology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009695 |
| Fax |
|
| Email |
khurana.dheeraj@pgimer.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dheeraj Khurana |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Neurology, PGIMER, Chandigarh
Department of Neurology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009695 |
| Fax |
|
| Email |
khurana.dheeraj@pgimer.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mandeep |
| Designation |
Women Scientist |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Neurology, PGIMER, Chandigarh
Department of Neurology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888124449 |
| Fax |
|
| Email |
axon.mandeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Women Scientist Scheme (WOS B) KIRAN Division, Department of Science and Technology (DST), Technology Bhawan, New Mehrauli Road, New Delhi- 110016. |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
KIRAN Division, Department of Science and Technology (DST), Technology Bhawan, New Mehrauli Road, New Delhi- 110016. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priti Arun |
Government Medical College and Hospital |
Department of Psychiatry, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9646121612
drpritiarun@gmail.com |
| Dr Dheeraj Khurana |
Post Graduate Institute of Medical Education and Research |
Department of Neurology
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
7087009695
khurana.dheeraj@pgimer.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
| Institutional Ethics Core Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Intervention and Physical Intervention
Duration and Frequency:
45 minutes
6 days a week
|
Cognitive Rehabilitation Intervention- Restorative and compensatory cognitive rehabilitation
Physical Rehabilitation Intervention- Walking, Balance exercises, Strengthening Exercises, Range of Motion Exercises, |
| Comparator Agent |
Standard of Care |
Medication and general instructions by treating physician |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Literacy level - High school completed (minimum qualification 10th Standard)
2. A baseline MoCA (Montreal Cognitive Assessment) score- 18 -25
3. DSM 5 diagnostic criteria for mild neuro cognitive disorder
4. Be screened safe for exercise by a physician
5. Normal auditory/visual acuity (with/without spectacles; no hearing aid)
6. Able to comply with rehabilitation program and can come for follow up
7. Willing to participate in the study and signed Informed consent.
8. Patients who have provided written consent and are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Severe Dementia (Clinical Dementia Rating Score>1) Alzheimer’s Disease or other progressive neurodegenerative /neuropsychiatric diseases.
2. Depression (Geriatric Depression Scale score 0-9)
3. Reversible dementia (Vit B12 deficiency, Thyroid dysfunction)
4. Any clinical dementia with co-existing neuropsychiatric disorder/head injury or terminal illness/ progressive neurodegenerative disorder.
5. Unstable cardiovascular disease that precludes exercise
6. Musculoskeletal impairments/pain or co-morbidities that limit ability to exercise/walk/use of walking aid. Berg balance scale score <40
7. Patient taking drugs that affect cognition (opioids, anti-psychotics/anticholinergics, tricyclic, anti-depressants, mood stabilizers, benzodiazepines and non- benzodiazepine, hypnotics, muscle relaxants, antihistamines, anti-epileptics)
8. History of prolonged alcohol or substance abuse
|
|
|
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 |
IQ CODE
SF-36 (rand)
IADL-EDR |
Baseline,4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICMR-NTB
Memory, Attention and Executive Function Domains
Category Fluency, Verbal Memory, TMT, Picture Naming, Immediate Recall, Interference Test, Free recall, Cued recall, Spatial Recall
|
1-Month
3- Month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mild Cognitive Impairment and Dementia are common health problems faced by adults and the elderly. Objective evidence of cognitive impairment is evident in both conditions. Directing cognitive and physical rehabilitation may improve the cognitive impairment. Evidences suggests physical and cognitive activities benefit the cognition.
The main objective of this study is to find the effectiveness of combined physical and cognitive rehabilitation in improving the cognitive impairment.
Study Design- Randomised control trial
Research Setting- Departmnet of Neurology, PGIMER, Chandigarh
Study Population- Mild Cognitive Impairment and Mild Dementia
Sample Size- 60 patients- 30 patients in each arm.
Recruitment Criteria- Inclusion criteria- 1) 45-70 years age 2) literacy level- at least 10th standard 3) MoCA score- 14-25 4) Normal auditory/ visual acuity )with/wothout spectacles and hearing aid) 5) Able to comply with rehabilitation program 6) willing to participate in thestudy and signed informed consent Exclusion Criteria- 1) Severe Dementia (Clinical Dementia rating scale>1) Alheimer’s disease or other progressive neurodegenerative / neuropsychiatric disease 2) Depression, Reversible dementia andclinical dementia with co-existing neuropsychiatric disorder/ head injury or terminal illnesses. 3) Unstable cardiovascular disease that preclude ofysical exercises 4) Musculoskeletal impairments or co-morbidities that limit ability to do exercises Berg balancescale <40 5) Ptient taking drugs that affect cognition 6) History of prolonged alcohol or substance abuse.
Patient recruitment- Study participants will be randomly assigned by simple ransomization into intervention group and control group. Intervention group will receive combined cognitive and physical rehabilitation. Control group will receive standard of care.
Primary Outcome- IQ CODE, SF 36 (RAND) , IADL-EDR Secondary Outcome- Attention, Memory and Executive domains of ICMR-NTB.
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