Trial Outcomes & Findings for A Multidomain Intervention Program for Older People With Dementia (NCT NCT04948450)

NCT ID: NCT04948450

Last Updated: 2025-04-06

Results Overview

Percentageof sessions attended out of the total planned

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-04-06

Participant Flow

Participant milestones

Measure	Intervention Group The multidomain intervention comprised: (1) physical activity; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation sessions were conducted separately, each held twice a week. Social intervention was integrated into the physical and cognitive intervention sessions. For the management of metabolic and vascular risk factors, participants received education on the importance of minimizing these risks, guidance on adopting healthier lifestyles, and treatment recommendations when necessary, provided by cardiologists and endocrinologists.	Control Group The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	27
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Intervention Group The multidomain intervention comprised: (1) physical activity; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation sessions were conducted separately, each held twice a week. Social intervention was integrated into the physical and cognitive intervention sessions. For the management of metabolic and vascular risk factors, participants received education on the importance of minimizing these risks, guidance on adopting healthier lifestyles, and treatment recommendations when necessary, provided by cardiologists and endocrinologists.	Control Group The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Overall Study Return home	1	3

Baseline Characteristics

A Multidomain Intervention Program for Older People With Dementia

Baseline characteristics by cohort

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Age, Continuous Number	78 years STANDARD_DEVIATION 7.4 • n=5 Participants	78 years STANDARD_DEVIATION 8.8 • n=7 Participants	78 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Vietnam	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Severity of dementia Mild	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Severity of dementia Moderate	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Adherence was only assessed for the intervention group

Percentageof sessions attended out of the total planned

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Adherence	85.4 percentage of Adherence	—

PRIMARY outcome

Timeframe: 6 months

The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Retention	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); score ranging from 0-70, a higher score indicates worse impairment.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Global Cognition After intervention (6 months)	27.3 score on a scale Standard Deviation 9.5	29.1 score on a scale Standard Deviation 9.9
Global Cognition Baseline	28 score on a scale Standard Deviation 8.8	24.5 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Executive Function Via Clock Drawing Test Baseline	0.5 score on a scale Standard Deviation 1.6	2.3 score on a scale Standard Deviation 3
Executive Function Via Clock Drawing Test After intervention	2.3 score on a scale Standard Deviation 3.4	2.7 score on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Attention Function Via Digit Span Forward Baseline	8.9 score on a scale Standard Deviation 2.5	9.5 score on a scale Standard Deviation 2.2
Attention Function Via Digit Span Forward After intervention	9 score on a scale Standard Deviation 2.2	9.1 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Atttention Function Will be Assessed Using Digit Span Backward. Baseline	2.5 score on a scale Standard Deviation 1.5	2.6 score on a scale Standard Deviation 1.3
Atttention Function Will be Assessed Using Digit Span Backward. After intervention	2.7 score on a scale Standard Deviation 1.5	3 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Behavioral and psychological symptoms of dementia (BPSD) will be measured using the Neuropsychiatric Inventory (NPI) questionnaire. The total NPI score ranging from 0 to 144 points. Higher scores indicate greater severity of BPSD

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Behavioral and Psychological Symptoms of Dementia (BPSD) Baseline	1 score on a scale Standard Deviation 1.7	1 score on a scale Standard Deviation 1.9
Behavioral and Psychological Symptoms of Dementia (BPSD) After intervention	0.8 score on a scale Standard Deviation 1.7	0.9 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Total Dependence of Participants Assessed Using the Barthel Index Total dependent (baseline)	4 participants	2 participants
Total Dependence of Participants Assessed Using the Barthel Index Total dependent (After intervention)	4 participants	7 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Functional Ability Via the Handgrip Strength Baseline	8 kilograms Standard Deviation 7.5	12.4 kilograms Standard Deviation 14.7
Functional Ability Via the Handgrip Strength After intervention	12.8 kilograms Standard Deviation 6.4	11.1 kilograms Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Count the total number of complete stands executed in 30 seconds

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Functional Ability Via 30 Seconds Sit To Stand Test Baseline	4.5 events Standard Deviation 4.2	3.4 events Standard Deviation 4.6
Functional Ability Via 30 Seconds Sit To Stand Test After intervention	5.4 events Standard Deviation 3.9	1.9 events Standard Deviation 4

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Falls will be assessed by the fall incident report at baseline and during the study period

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Fall Baseline	11 Participants	8 Participants
Fall After intervention	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Quality of Sleep Poor sleep (baseline)	26 participants	17 participants
Quality of Sleep Poor sleep (after intervention)	19 participants	17 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Health-related quality of life will be assessed using the Quality of Life in Alzheimer's Disease scale. The Quality of Life in Alzheimer's Disease scale measures the overall quality of life in individuals with Alzheimer's disease. It consists of 13 items, each rated on a 4-point Likert scale. The total score is obtained by summing the scores of all 13 items, resulting in a possible range from 13 to 52 points. Higher scores indicate a better quality of life.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Health-related Quality of Life Baseline	27.3 score on a scale Standard Deviation 4.4	33.6 score on a scale Standard Deviation 4.6
Health-related Quality of Life After intervention	28.9 score on a scale Standard Deviation 4.3	34.4 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 6 months

Death will be assessed through reports from care staff, nursing home records.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Death	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Functional ability will be assessed using the Instrumental Activities of Daily Living Scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Functional Ability Via the Instrumental Activities of Daily Living Scale Dependent (baseline)	26 participants	29 participants
Functional Ability Via the Instrumental Activities of Daily Living Scale Dependent (After intervention)	23 participants	27 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data were analyzed on an intention-to-treat

Dependence will be assessed using the Instrumental Activities of Daily Living scale, which evaluates the ability to perform eight daily tasks, including using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and financial management. The total score ranges from 0 to 8, with 8 indicating full independence and scores below 8 suggesting dependence in functional activities.

Outcome measures

Measure	Intervention Group n=30 Participants Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions	Control Group n=30 Participants The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale Dependent (baseline)	26 participants	29 participants
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale Dependent (After intervention)	23 participants	27 participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nguyen Xuan Thanh

National Geriatric Hospital

Phone: 0983277646

Email: xuanthanhbmlk@hmu.edu.vn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place