Brain Exercises for better memory

Recruiting

• Conditions: Diseases of the nervous system,

• Registration Number: CTRI/2021/03/031965
• Lead Sponsor: Department of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IQ CODE	Baseline,4 weeks and 8 weeks
SF-36 (rand)	Baseline,4 weeks and 8 weeks
IADL-EDR	Baseline,4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
ICMR-NTB	Memory, Attention and Executive Function Domains

Trial Locations

Locations (2)

Government Medical College and Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital

🇮🇳Chandigarh, CHANDIGARH, India

Dr Priti Arun

Principal investigator

9646121612

drpritiarun@gmail.com