An interventional study of Physical activity intervention and Cognitive stimulation intervention in Dementia, Alzheimer Disease and Dementia, Mixed, sponsored by National Geriatric Hospital. Completed at 4 sites in Vietnam. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by National Geriatric Hospital · Not applicable, Interventional, and Supportive care
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, and death rate compared to those in the control group during the 6 months intervention period
This is a two-armed, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam.
The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained.
Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group).
Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association.
All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors.
In addition to what is given to both groups, participants in the intervention group will receive four intervention components: (1) physical activity intervention; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions.
All outcome measures will be administered at baseline, 6 months
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →National Geriatric Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
Exclusion criteria are:
g. Participant or family unwilling to participate in the study
Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.
Behavioral: Physical activity intervention · Behavioral: Cognitive stimulation intervention · Behavioral: Social intervention · Other: Management of metabolic and vascular risk factors
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.
Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home for 45 minutes twice a week. The sessions will be organized in groups (6-10 patients/ group) and supervised by 2 physiotherapists. Within each small group (maximum 10), participants will follow the program tailored to their individual functioning level, with constant oversight by trainers. People with dementia and care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily.
The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (6-10 patients/ group). People with dementia and their care staff will be instructed on how to practice the various activities at their nursing home for the rest of the week.
Social intervention will be combined with physical and cognitive interventions through doing these in a group, playing games during exercises (dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group.
Study physicians will assess the risk of developing new chronic diseases, change in blood pressure, weight and BMI, and hip and waist circumference, blood test (glucose, lipid parameters, fasting glucose, and HbA1C if the person with dementia has diabetes) at 3 and 6 months. Participants in the intervention group will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 8 %.
Adherence
Percentageof sessions attended out of the total planned
Time frame: 6 months
Retention
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
Time frame: 6 months
Global Cognition
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.
Time frame: Baseline, 6 months
Executive Function Via Clock Drawing Test
Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment
Time frame: Baseline, 6 months
Attention Function Via Digit Span Forward
Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention
Time frame: Baseline, 6 months
Atttention Function Will be Assessed Using Digit Span Backward.
Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention
Time frame: Baseline, 6 months
Behavioral and Psychological Symptoms of Dementia (BPSD)
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
Time frame: Baseline, 6 months
Total Dependence of Participants Assessed Using the Barthel Index
Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.
Time frame: Baseline, 6 months
Functional Ability Via the Handgrip Strength
Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability
Time frame: Baseline, 6 months
Functional Ability Via 30 Seconds Sit To Stand Test
Count the total number of complete stands executed in 30 seconds
Time frame: Baseline, 6 months
Fall
Falls will be assessed by the fall incident report at baseline and during the study period
Time frame: Baseline, 6 months
Quality of Sleep
Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers
Time frame: Baseline, 6 months
Health-related Quality of Life
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.
Time frame: Baseline, 6 months
Death
Death will be assessed through reports from care staff, nursing home records.
Time frame: 6 months
Functional Ability Via the Instrumental Activities of Daily Living Scale
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.
Time frame: Baseline, 6 months
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale
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.
Time frame: Baseline, 6 months
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 27 |
| Not completed | 1 | 3 |
| Withdrew: Return home | 1 | 3 |
Percentageof sessions attended out of the total planned
| percentage of Adherence | Intervention Group | Control Group |
|---|---|---|
| Adherence | 85.4 | — |
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Retention | 1 | 3 |
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.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 28 ± 8.8 | 24.5 ± 8.5 |
| After intervention (6 months) | 27.3 ± 9.5 | 29.1 ± 9.9 |
Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 0.5 ± 1.6 | 2.3 ± 3 |
| After intervention | 2.3 ± 3.4 | 2.7 ± 3.8 |
Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 8.9 ± 2.5 | 9.5 ± 2.2 |
| After intervention | 9 ± 2.2 | 9.1 ± 2.8 |
Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 2.5 ± 1.5 | 2.6 ± 1.3 |
| After intervention | 2.7 ± 1.5 | 3 ± 1.3 |
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
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 1 ± 1.7 | 1 ± 1.9 |
| After intervention | 0.8 ± 1.7 | 0.9 ± 1.7 |
Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.
| participants | Intervention Group | Control Group |
|---|---|---|
| Total dependent (baseline) | 4 | 2 |
| Total dependent (After intervention) | 4 | 7 |
Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability
| kilograms | Intervention Group | Control Group |
|---|---|---|
| Baseline | 8 ± 7.5 | 12.4 ± 14.7 |
| After intervention | 12.8 ± 6.4 | 11.1 ± 6.1 |
Count the total number of complete stands executed in 30 seconds
| events | Intervention Group | Control Group |
|---|---|---|
| Baseline | 4.5 ± 4.2 | 3.4 ± 4.6 |
| After intervention | 5.4 ± 3.9 | 1.9 ± 4 |
Falls will be assessed by the fall incident report at baseline and during the study period
| Participants | Intervention Group | Control Group |
|---|---|---|
| Baseline | 11 | 8 |
| After intervention | 6 | 7 |
Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers
| participants | Intervention Group | Control Group |
|---|---|---|
| Poor sleep (baseline) | 26 | 17 |
| Poor sleep (after intervention) | 19 | 17 |
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.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline | 27.3 ± 4.4 | 33.6 ± 4.6 |
| After intervention | 28.9 ± 4.3 | 34.4 ± 4.1 |
Death will be assessed through reports from care staff, nursing home records.
| participants | Intervention Group | Control Group |
|---|---|---|
| Death | 0 | 0 |
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.
| participants | Intervention Group | Control Group |
|---|---|---|
| Dependent (baseline) | 26 | 29 |
| Dependent (After intervention) | 23 | 27 |
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.
| participants | Intervention Group | Control Group |
|---|---|---|
| Dependent (baseline) | 26 | 29 |
| Dependent (After intervention) | 23 | 27 |
Collected over For each participant, adverse events were collected for the duration of participation in the study (up to 6 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 29 | 28 | 57 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Number | 78 ± 7.4 | 78 ± 8.8 | 78 ± 8 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 21 | 20 | 41 |
| Male | 9 | 10 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 30 | 30 | 60 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Vietnam | 30 | 30 | 60 |
| Severity of dementia(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mild | 11 | 11 | 22 |
| Moderate | 19 | 19 | 38 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Geriatric Hospital