Brain Exercises for better cognitive functioning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- IQ CODE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Literacy level.
- •High school completed (minimum qualification 10th Standard)
- •A baseline MoCA (Montreal Cognitive Assessment) score- 18 -25
- •DSM 5 diagnostic criteria for mild neuro cognitive disorder
- •Be screened safe for exercise by a physician
- •Normal auditory/visual acuity (with/without spectacles; no hearing aid)
- •Able to comply with rehabilitation program and can come for follow up
- •Willing to participate in the study and signed Informed consent.
- •Patients who have provided written consent and are willing to participate in the study.
排除标准
- •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.
结局指标
主要结局
IQ CODE
时间窗: Baseline,4 weeks and 8 weeks
SF-36 (rand)
时间窗: Baseline,4 weeks and 8 weeks
IADL-EDR
时间窗: Baseline,4 weeks and 8 weeks
次要结局
- ICMR-NTB(Memory, Attention and Executive Function Domains)