Effectiveness of Non-pharmacological Interventions for Dementia Among Elderly in Hai Duong Province, Vietnam

NCT05351723 | Completed

• 1 other identifier: #HMUIRB476#
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled intervention aimed at improving cognitive decline in patients with dementia. The program includes exercise, cognitive training, and dementia education. The output index is expected to be an improvement in cognition, accompanied by an improvement in fitness, sleep quality, reduction in depression levels, and an improvement in quality of life. This is a program that is expected to be effective, inexpensive, easy to apply and does not require high expertise. A total of 50 dementia patients diagnosed and managed by the National Geriatric Hospital, Hai Duong Province General Hospital will be included in the study for 6 months. Patients were randomly assigned to an intervention group and received a program of physical exercise, cognitive training, dementia lecture, and long-term follow-up, or entered a control group to hear a lecture. about dementia. Cognition and fitness will be assessed after follow-up at 0, 3, and 6 months. This work is sponsored by Vingroup Joint Stock Company and supported by domestic Masters/Ph.D. The scholarship program of Vingroup Innovation Fund (VINIF), Vingroup Big Data Institute (VINBIGDATA).

Conditions

Dementia

Keywords

Non-pharmacological interventions; Dementia; Elderly; Randomized Control

Outcome Measures

Primary Outcomes (1)

• Changes from Clinical Dementia Rating Questionnaire at 3, and 6 months

  The questionnaire consists of 2 parts: Part 1 is for information providers (relatives/carers), part 2 is for patients, comparing the information provided to evaluate sixaspects, including Memory, Force Orientation, Evaluation - problem-solving, Social activities, Housework - hobbies and Self-care. The study will stimulate both the component scores and the total scores for the dementia grade. The sensitivity of the CDR was 93.6%, a specificity of 100%1. The CDR scale is divided into 5 levels: 0 (No Dementia), 0.5 (Very Mild Dementia), 1 (Mild Dementia), 2 (Moderate Dementia), 3 (Severe dementia).The higher the score, the more severe the dementia

  Baseline, 3, and 6 months post intervention

Secondary Outcomes (4)

• Changes from International Physical Activity Questionnaire - Short Form at 3, and 6 months

  Baseline, 3, and 6 months post intervention

• Changes from Pittsburgh sleep quality index at 3, and 6 months

  Baseline, 3, and 6 months post intervention

• Changes from Geriatric Depression Scale-15 at 3, and 6 months

  Baseline, 3, and 6 months post intervention

• Changes from EuroQoL-5 dimensions-5 levels at 3, and 6 months

  Baseline, 3, and 6 months post intervention

Study Arms (2)

Exercise + cognitive training + education

EXPERIMENTAL

Intervention group: each session comprises (1) 50 min of physical exercise, (2) 20 min of break time or education on dementia and lifestyle habits, and (3) 50 min of cognitive training.

Other: Exercise + cognitive training + education

Education

OTHER

Control group: education on dementia and lifestyle habits.

Other: Exercise + cognitive training + education

Interventions

Exercise + cognitive training + education OTHER

The research team will record videos for the Intervention group. The intervention procedure includes 3 sections: (1) 50 min of physical exercise, (2) 20 min of break time or lecture on dementia and lifestyle habits, and (3) 50 min of cognitive training. Investigators will be recruited from the National Geriatrics Hospital and trained the technicians for 1 week. Prior to intervening, patients who agree to participate will be screened and evaluated cognitive function, physical function, assessment of Activities of Daily Living, quality of life, depression, anxiety, stress, and sleep quality. Technicians will record every training session, monitor participants' health, and ensure that those in the intervention group do the exercises correctly. We will evaluate the participants in the group after 3 months and after 6 months of intervention.

Education; Exercise + cognitive training + education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly (aged 60 years or above).
• Living in Thanh Mien district and Gia Loc district of Hai Duong province.
• Diagnosed with very mild, mild and moderate dementia by the Clinical Dementia Assessment (CDR) Questionnaire, corresponding to CDR = 0.5, CDR = 1 and CDR = 2.

You may not qualify if:

• Not physically fit to participate in physical exercises.
• Having cardiovascular diseases.

Sponsors & Collaborators

• Hanoi Medical University: lead
• National Geriatric Hospital: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Dementia

Interventions

Exercise; Cognitive Training; Educational Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * Before the intervention, the research team will record the video for each group: * Intervention group: each session comprises (1) 50 min of physical exercise, (2) 20 min of break time or education on dementia and lifestyle habits, and (3) 50 min of cognitive training. * Control group: education on dementia and lifestyle habits. * Prior to intervening, patients who agree to participate will be screened and evaluated cognitive function, physical function, assessment of Activities of Daily Living, quality of life, depression, anxiety, stress, and sleep quality. * We will randomly divide the patients into the intervention-control group at each commune. Each group will attend an "intervention program" once a week within six months. * We will evaluate the participants in two groups twice after 3 months and after 6 months of intervention.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 28, 2022
• Study Start: June 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 15, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

VN (1)