Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers

NCT06597981 | Recruiting DMC

• 1 other identifier: UW 24-395
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Health-related quality of life

  The Short Form 12-item Health Survey-version two (SF-12v2) scale will be used to obtain the patient's health-related quality of life (HRQOL). The sum scores range from 0 to 100, with a higher score representing better HRQOL.

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Global cognition

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be used to evaluate global cognition. The sum scores range from 0 to 70, with a higher score representing poorer cognitive function.

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Relationship quality

  The Dyadic Relationship Scales (Chinese version, DRS), which includes two independent scales (DRS-patient and DRS-caregiver versions) will be used to measure the quality of dyadic relationship between family dyads. The sum scores of DRS-patient range from 0 to 27 and the sum scores of DRS-caregiver range from 0 to 30, with a higher score representing poorer relationship quality.

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

Secondary Outcomes (6)

• Memory function

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Processing speed and executive function

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Behavioral and psychological symptoms of dementia

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Expressed emotion

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

• Burden

  baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

Study Arms (2)

Dyadic empowerment-based sport stacking group

EXPERIMENTAL

Behavioral: Dyadic empowerment-based sport stacking

Basic education group

ACTIVE COMPARATOR

Other: Basic education

Interventions

Dyadic empowerment-based sport stacking 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.

Dyadic empowerment-based sport stacking group

Basic education 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).

Basic education group

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Researchers may submit data requests beginning 9 months after article publication, with access available for up to 24 months. Extensions can be considered on a case-by-case basis.
• Access Criteria: Qualified researchers conducting independent scientific research can request access to trial IPD. This access will be granted after the review and approval of a research proposal and Statistical Analysis Plan (SAP), along with the execution of a Data Sharing Agreement (DSA).

Locations

CN (1)