A Multidomain Intervention Program for Older People With Dementia
NCT ID: NCT04948450
Last Updated: 2025-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-11-24
2024-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention group
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.
Physical activity intervention
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.
Cognitive stimulation intervention
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
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.
Management of metabolic and vascular risk factors
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 %.
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.
No interventions assigned to this group
Interventions
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Physical activity intervention
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.
Cognitive stimulation intervention
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
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.
Management of metabolic and vascular risk factors
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 %.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Symptomatic cardiovascular disease, coronary revascularization within 1 year
3. Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
4. Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
5. Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
g. Participant or family unwilling to participate in the study
60 Years
ALL
No
Sponsors
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National Geriatric Hospital
OTHER_GOV
Responsible Party
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Nguyen Xuan Thanh
Deputy Head of Palliative care department
Principal Investigators
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Anh T Nguyen, PhD
Role: STUDY_DIRECTOR
National Geriatric Hospital
Thanh X Nguyen, MS
Role: PRINCIPAL_INVESTIGATOR
National Geriatric Hospital
Locations
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Dien Hong nursing home
Hanoi, , Vietnam
National Geriatric Hospital
Hanoi, , Vietnam
Nhan Ai nursing home
Hanoi, , Vietnam
Orihome
Hanoi, , Vietnam
Countries
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References
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Duong S, Patel T, Chang F. Dementia: What pharmacists need to know. Can Pharm J (Ott). 2017 Feb 7;150(2):118-129. doi: 10.1177/1715163517690745. eCollection 2017 Mar-Apr. No abstract available.
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
Bich NN, Dung NTT, Vu T, Quy LT, Tuan NA, Binh NTT, Hung NT, Anh LV. Dementia and associated factors among the elderly in Vietnam: a cross-sectional study. Int J Ment Health Syst. 2019 Aug 23;13:57. doi: 10.1186/s13033-019-0314-7. eCollection 2019.
GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422(18)30403-4. Epub 2018 Nov 26.
Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
Fink HA, Jutkowitz E, McCarten JR, Hemmy LS, Butler M, Davila H, Ratner E, Calvert C, Barclay TR, Brasure M, Nelson VA, Kane RL. Pharmacologic Interventions to Prevent Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):39-51. doi: 10.7326/M17-1529. Epub 2017 Dec 19.
Nguyen TA, Pham T, Dang TH, Hinton WL, Nguyen AT, Pham TL, Crotty M, Kurrle S, Bui QT, Nguyen H, Roughead EE. Towards the development of Vietnam's national dementia plan-the first step of action. Australas J Ageing. 2020 Jun;39(2):137-141. doi: 10.1111/ajag.12755. Epub 2019 Dec 9.
Streater A, Spector A, Aguirre E, Hoe J, Hoare Z, Woods R, Russell I, Orrell M. Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial. Trials. 2012 Jun 26;13:91. doi: 10.1186/1745-6215-13-91.
Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CB1.02
Identifier Type: -
Identifier Source: org_study_id
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