Multidomain Intervention Programs for Older People With Dementia With Dementia

Sponsor

National Geriatric Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04948450

Collaborator

(none)

174

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a intervention study aims to investigate the effects of a multidomain intervention program for older people with vascular and mixed Alzheimer's and vascular dementia. 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 and cognitive interventions, and management of metabolic and vascular risk factors. The primary outcome is changes in cognitive function measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) 13-item version. We hypothesize that the multidomain intervention will improve cognitive function, quality of life, behaviours, functional ability, sleep and reduce falls, use of healthcare services, death in the study group compared to the control group during the 6 months intervention period and after the 6 months extended follow-up.

Condition or Disease	Intervention/Treatment	Phase
Dementia, Vascular Dementia, Mixed	Behavioral: Physical activity intervention Behavioral: Cognitive stimulation intervention Other: Reduce of metabolic and vascular risk factors	N/A

Detailed Description

After initial screening, participants and their caregivers will receive a complete explanation of the purpose, risks, and procedures of the study and sign a written informed consent if they show interest in participating. Those agreeing 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 and cognitive interventions, and management of metabolic and vascular risk factors.

Both the intervention and the control group participants will be treated for dementia according to the recommendations of the Vietnam Alzheimer 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, and 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). Blood pressure measurements will be made on the left arm of the seated participants with a sphygmomanometer and an appropriately sized cuff; the average of 2 physician-obtained measures constituted the examination blood pressure. Metabolic and vascular risk factors will be ascertained by self-report (or caregivers report). Diabetes was defined as fasting glucose > 7 mmol/l or use of insulin or oral hypoglycemic medications. Hypertension is defined as a systolic blood pressure of 140 mm Hg or more, or a diastolic blood pressure of 90 mm Hg or more, or taking antihypertensive medication. Dyslipidemia is defined as having a high plasma triglyceride concentration, low high-density lipoprotein cholesterol (HDL-C) concentration, and decreased concentration of low-density lipoprotein cholesterol (LDL-C). Results will be provided to participants and their doctors.

Interventions

The intervention group:

In addition to what is given to both groups, the participants in intervention group will receive three intervention components: (1) physical activity; (2) cognitive intervention; and (3) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed on separate time.

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 (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.

The exercise program consists of progressive resistance training. Participants will progress through the 6-month intervention, guided by daily ratings of perceived exertion (15-18) on the Borg Scale [19].

People with dementia and their caregivers will be instructed to follow the prescribed home-based PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily. Physiotherapists will determine progress subjectively based on the ability of the person with dementia. Training volume (multiplying the number of repetitions performed/day by the number of days) will be monitored using a simple training diary with compliance assessed as a measure of practice ratio i.e. number of days the subjects actually carried out the program multiplied by the program duration in days

Cognitive intervention The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy [20] with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (10 patients/ group) Each session lasts about 45 minutes. To make sure that there is continuity between the sessions they will follow the same structure: introductions (l0 minutes), main activity (25 minutes) and conclusion (l0 minutes). A total set of 14 exercises will be selected including physical games, sounds, childhood, food, current affairs, word associalion, being creative, categorising objects, orientation, using money, number game, word games, team quiz, which will be culturally adapted in Vietnam. Necessary activities related to daily lives will also included and the activities were in a group-based setting. People with dementia and their caregivers will be instructed on how to practice at nursing home for the rest of the week. Training volume (multiplying the number of repetitions performed/day by the number of days) will be monitored using a simple training diary Management of metabolic and vascular risk factors Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.

Study physicians will assess the incidence rate of new chronic disease, 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, 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 cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7.5 %

The control group:

The control group will receive general health advice every 3 months based on their physical examination and blood findings. They will be provided information on the vascular risk factors for dementia and will be received instruction and handouts on diet, exercise.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Multidomain Intervention Programs for Older People With Dementia

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Physical activity intervention: Individual progressive resistance training with physiotherapists Cognitive stimulation intervention: Cognitive Stimulation Therapy with rehabilitation experts. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists. The study subjects will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7.5 %	Behavioral: Physical activity intervention Individual progressive resistance training with physiotherapists Behavioral: Cognitive stimulation intervention Cognitive Stimulation Therapy with rehabilitation experts. Other: Reduce of metabolic and vascular risk factors Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists. The study subjects will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7 %
No Intervention: Control group The control group will receive general health advice every 3 months based on their physical examination and blood findings. They will be provided information on the vascular risk factors for dementia and will be received instruction and handouts on diet, exercise.

Arm

Intervention/Treatment

Experimental: Intervention group

Physical activity intervention: Individual progressive resistance training with physiotherapists Cognitive stimulation intervention: Cognitive Stimulation Therapy with rehabilitation experts. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists. The study subjects will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7.5 %

Behavioral: Physical activity intervention

Individual progressive resistance training with physiotherapists

Behavioral: Cognitive stimulation intervention

Cognitive Stimulation Therapy with rehabilitation experts.

Other: Reduce of metabolic and vascular risk factors

Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists. The study subjects will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7 %

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Cognitive performance [Change from Baseline Cognitive performance at 6 months and 12 months]
Cognitive performance will be assessed using Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) 13-item version

Secondary Outcome Measures

Dementia severity using Clinical Dementia Rating [Change from Baseline Dementia severity at 6 months and 12 months]
Dementia severity will be assessed using Clinical Dementia Rating
Dementia severity using Mini-Mental State Examination [Change from Baseline Dementia severity at 6 months and 12 months]
Dementia severity will be assessed using Mini-Mental State Examination
Memory function [Change from Baseline Memory function at 6 months and 12 months]
Memory function will be assessed using Recall test
Excutive function using Clock drawing test [Change from Baseline Clock drawing test at 6 months and 12 months]
Excutive function will be assessed using Clock drawing test
Excutive function using Trails B test [Change from Baseline Trails B test at 6 months and 12 months]
Excutive function will be assessed using Trails B test
Attention function using digit span forward [Change from Baseline Attention function at 6 months and 12 months]
Attention function will be assessed using digit span forward
Attention function using Trials A and B test [Change from Baseline Attention function at 6 months and 12 months]
Attention function will be assessed using Trials A and B test
Behaviours (agitation, aggression) [Change from Baseline Behaviours at 6 months and 12 months]
Behaviours will be assessed using Neuropsychiatric Inventory (NPI) questionare
Functional ability using Barthel index [Change from Baseline Functional ability at 6 months and 12 months]
Functional ability will be assessed using Barthel index
Functional ability using the Short Physical Performance Battery (SPPB) [Change from Baseline Functional ability at 6 months and 12 months]
Functional ability will be assessed the Short Physical Performance Battery (SPPB)
Functional ability using the handgrip strength [Change from Baseline Functional ability at 6 months and 12 months]
Functional ability will be assessed the handgrip strength
Prevalence of fall [Change from Baseline Prevalence of fall at 6 months and 12 months]
Prevalence of fall will be assessed through questionnaire
Fall risks [Change from Baseline Fall risks at 6 months and 12 months]
Fall risks will be assessed using Timed Up & Go test
Quality of sleep [Change from Baseline Quality of sleep at 6 months and 12 months]
Quality of sleep will be assessed using Pittsburgh Sleep Quality Index
Completers [6 months]
Completers defines as completing at least 70% of exercises and at least three follow-ups, one of which must be the final follow-up at 12 months

Other Outcome Measures

Utilization of health resources [6 months and 12 months]
Utilization of health resources will be assessed using questionnaire
Death [6 months and 12 months]
Death will be assessed using questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of mild-moderate vascular dementia or mixed dementia according to DSM 5 criteria. 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 mobilise independently with or without a mobility aid and without physical assistance.

Exclusion criteria are:

Acute and malignant diseases (advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
Symptomatic cardiovascular disease, coronary revascularization within 1 year
Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-IV TR criteria)
Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
Severe loss of vision, hearing or communicative ability (according to the interRAI Community Health Assessment)