Effectiveness of Non-pharmacological Interventions for Dementia Prevention in Elderly Patients With Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorGia Dinh People Hospital

About this trial

The aims of this study is to evaluate the effectiveness of non-pharmacological interventions program in preventing progression from mild cognitive impairment to dementia in patients with mild cognitive impairment in the short term, at Nhân dân Gia Định Hospital, Hồ Chí Minh City.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cognitive complaints from the subject or a family member.

Report a decline in cognitive function compared to the subject's previous ability over the past year OR

Evidence from clinical assessment, specifically here is MMSE screening with results of 24-29 points.

Subjects did not suffer major impacts from cognitive complaints on daily life.

Disqualifiers

Don't know Vietnamese writing.

Audio-visual ability does not meet the requirements of assessment tests and prevention programs.

Systemic diseases are contraindications/ restriction to participation in programs and/or cause secondary cognitive impairment (traumatic brain injury, stroke, brain tumor, parkinsonism, epilepsy, acute coronary artery disease, acute myocardial infarction, bone fractures...).

The assessment score on the Geriatric Depression Scale (GDS-15) is ≥ 5 points.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-based cognitive training exercises

    Other intervention

    The subjects received (i) education on lifestyle modification, (ii) home-based cognitive training exercises with physiotherapist/ physiatrist contact when needed and (iii) a physical training exercises conducted at hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks.

  • Supervised cognitive training exercises

    Other intervention

    The subjects received (i) education on lifestyle modification, (ii) supervised cognitive training exercises at hospital (1 weekly session for 12 weeks) and (iii) a physical training exercises conducted in a hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Home-based cognitive training exercisesActive comparator 1 intervention
Group B: Supervised cognitive training exercisesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness of Intervention Program

Evaluating the effectiveness of preventing progression from mild cognitive impairment to dementia using the Montreal Cognitive Assessment (The MoCA Test) in patients with mild cognitive impairment in the short term. Higher scores mean a better outcome. The following result ranges may indicate cognitive impairment: 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.

Time frame
Measured at month 3 and 6 after randomisation

Secondary outcomes

1

Change in Activities of Daily Living

Evaluating improvement using The Lawton Instrumental Activities of Daily Living Scale (IADL). Higher scores mean a better outcome.

Time frame
Baseline, Week12, Week24
2

Change in physical fitness

Evaluating improvement using The Senior Fitness Test Kit (Chair stand test, Arm curl test, Step in place test, Up and go test). Higher scores mean a better outcome (except Up and go test).

Time frame
Baseline, Week12, Week24
3

Change in mental health

Evaluating improvement using Geriatric Depression Scale-15 (GDS15). Higher scores mean a worse outcome.

Time frame
Baseline, Week12, Week24
4

Patient Adherance

Adherence is assessed considering the number of individuals who have accepted to participate in the study relative to the number of participants who are recruited. Low \< 80%, moderate 80-90%, high \> 90%

Time frame
Week12

Other outcomes

Sponsors and contacts

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