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Multi-component intervention for the reversal of mild cognitive impairment and physical frailty

Multi-domain intervention for reversal of cognitive frailty: towards personalized approaches

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75429638
Enrollment
106
Registered
2021-06-01
Start date
2020-11-23
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive frailty in older adults Mental and Behavioural Disorders

Interventions

Current interventions as of 11/06/2025: The intervention group participated in a structured 24-month program, which began with vascular care, followed by nutritional guidance, psychological support,

Sponsors

National University of Malaysia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/06/2025: 1. 60 - 80 y old 2. Clinical Dementia Rating = 0.5 3. Mini-Mental State Examination Score (> 19) 4. Frailty (Fried criteria) > 3 _____ Previous inclusion criteria: 1. 60 - 80 y old 2. Clinical Dementia Rating = 0.5 3. Mini-Mental State Examination Score (> 19) 4. Frailty (Fried criteria) > 3 5. Cognitive screening will be conducted with the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) neuropsychological battery and participants have to meet at least one of the following criteria: word list memory task (ten words three times) results of 19 words or fewer; word list recall of 75% or less; or mini mental state examination of 26 points or less out of 30 points

Exclusion criteria

Exclusion criteria: 1. Suspected dementia after clinical assessment by study physician at screening visit (individuals recommended for further investigations) 2. Disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 y previously) 3. Severe loss of vision, hearing, or communicative ability 4. Coincident participation in another intervention trial

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 11/06/2025: The primary outcomes assessed in this study encompassed both cognitive and physical functions. Cognitive performance was evaluated using several measures, including digit span forward, digit span backward, total digit span, verbal paired associates (for both immediate and delayed recall), visual paired associates (immediate and delayed recall), the Rey Auditory Verbal Learning Test (RAVLT), and the Categorical Fluency Test. Physical function, meanwhile, was measured using a range of tests: the chair sit and reach test, back scratch test, timed up and go (TUG) test, 30-second sit-to-stand test, 6-minute walk test, and the 2-minute step test. _____ Previous primary outcome measure as of 02/06/2023: At baseline, 6, 12, 24 and 36 months: 1. Physical Function (Physical performance test, frailty indicators, cardiorespiratory fitness (VO2max), 2-min Step Test, Grip Strength Test, Chair Stand Test, Chair Sit-and-Reach Test, Timed Up-and-Go Test, Back Scratch Test, Gait speed, Exercise Self-Efficacy Scale (ESES)) 2. Cognitive Function (Mini Mental State Examination, modified Neuropsychological Test Battery) _____ Previous primary outcome measure: At baseline, 6, 12, 24 and 36 months: 1. Physical Function (Physical performance test, frailty indicators, cardiorespiratory fitness (VO2max), 2-min Step Test, Grip Strength Test, Chair Stand Test, Chair Sit-and-Reach Test, Timed Up-and-Go Test, Back Scratch Test, Gait speed, Exercise Self-Efficacy Scale (ESES)) 2. Cognitive Function (Mini Mental State Examination, Sleep pattern and insomnia, Medical Outcome Social Support (MOSS), BRIEF-Cope, Geriatric Depression Scale (GDS), UCLA loneliness scale, Resilience scale, General Self-Efficacy Scale (GSES) and University of Rhode Island Change Assessment (URICA) Psychotherapy version)

Secondary

MeasureTime frame
Current secondary outcome measures as of 11/06/2025: 1.15ml blood will be drawn to examine the vascular health that includes biochemical analysis (Fasting Blood Sugar, Fasting Serum Lipid, HBA1C], Troponin, Nitric oxide) as well as the nutriomes (level of albumin, Amino acid and fatty acids profile, vitamin D status and receptor, B12, Folic Acid, Vitamin E) 2. Psychosocial factors: Sleep pattern and insomnia, Medical Outcome Social Support (MOSS), BRIEF-Cope, Geriatric Depression Scale (GDS), UCLA loneliness scale, Resilience scale, General Self-Efficacy Scale (GSES) and University of Rhode Island Change Assessment (URICA) Psychotherapy version _____ Previous secondary outcome measures: At baseline, 6, 12 and 24 months: 1.15ml blood will be drawn to examine the vascular health that includes biochemical analysis (Fasting Blood Sugar, Fasting Serum Lipid, HBA1C], Troponin, Nitric oxide) as well as the nutriomes (level of albumin, Amino acid and fatty acids profile, vitamin D status and receptor, B12, Folic Acid, Vitamin E) 2. Environment and psychosocial factors: Sleep pattern and insomnia, Medical Outcome Social Support (MOSS), BRIEF-Cope, Geriatric Depression Scale (GDS), UCLA loneliness scale, Resilience scale, General Self-Efficacy Scale (GSES) and University of Rhode Island Change Assessment (URICA) Psychotherapy version

Countries

Malaysia

Contacts

Public ContactPavapriya;Devinder Kaur Ponvel;Ajit Singh

;

hcare@ukm.edu.my;devinder@ukm.edu.my+60 162714178;+60 392897352

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026