Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers

NCT ID: NCT06597981

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2026-05-31

Brief Summary

The goal of this clinical trial is to develop and test a dyadic empowerment-based sport stacking program to improve health outcomes of people with mild dementia and their family caregivers.

The research hypotheses to be tested are:

i) People with dementia who receive the dyadic empowerment-based sport stacking program will report a greater improvement in cognitive function, a greater reduction in cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms, and a greater improvement in health-related quality of life (HRQOL) at T1 (12th week) and T2 (18th week), compared to the usual care group; ii) Caregivers who receive the dyadic empowerment-based sport stacking program will report less stressful in managing the cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms and a greater improvement in HRQOL at T1 (12th week) and T2 (18th week), compared to the usual care group; iii) The care dyads who receive the dyadic empowerment-based sport stacking program will report less dyadic relationship strain at T1 (12th week) and T2 (18th week), compared to the usual care group.

For the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads/group) and three check-up/support sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads/group). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes/day, five times/week) for 6 weeks.

Participants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads/group) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).

Conditions

Dementia; Family Caregivers; Dyadic Intervention; Health Related Quality of Life; Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dyadic empowerment-based sport stacking group

Group Type: EXPERIMENTAL

Dyadic empowerment-based sport stacking

Intervention Type: BEHAVIORAL

For the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads/group) and three check-up/support sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads/group). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes/day, five times/week) for 6 weeks.

Basic education group

Group Type: ACTIVE_COMPARATOR

Basic education

Intervention Type: OTHER

Participants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads/group) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).

Interventions

Dyadic empowerment-based sport stacking

For the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads/group) and three check-up/support sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads/group). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes/day, five times/week) for 6 weeks.

Intervention Type: BEHAVIORAL

Basic education

Participants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads/group) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• People living with dementia (PLwD) : i) Clinical diagnosis of dementia, in accordance with the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-V); ii) a minimum age of 60 years; iii) Clinical Dementia Rating (CDR) score of 1; iv) home-dwelling; v) able to communicate with the research personnel to understand training program and assessments; vi) have adequate hearing and visual function to enable skill learning; vii) informed consent.

• Family caregivers: i) aged 18 years or above; ii) living with or providing care to PLwD at least 4 hours/day; iii) able to understand and communicate in Chinese; iv) have access to smartphone/iPad/laptop and are users of one of these devices; v) consent to participate.

Exclusion Criteria

• People living with dementia (PLwD) : i) severe mental and behavioral disorders; ii) any acute medical condition precluding participation in the program (e.g., pneumonia and cardiac insufficiency); iii) concurrent participation in other studies.

• Family caregivers: i) physically not able to participate in the sport stacking due to physical problems; ii) suffer from acute psychotic condition; iii) unable to support the PLwD in the delivery of sport stacking sessions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Yang Ziying

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ziying Yang

Role: primary

ziying1@connect.hku.hk

+86 15858807566

Other Identifiers

UW 24-395

Identifier Type: -

Identifier Source: org_study_id