Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers

Development and Testing of a Dyadic Empowerment-based Sport Stacking Program to Improve Health Outcomes of People With Mild Dementia and Their Family Caregivers

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).

Study Overview

• Status: Recruiting
• Conditions: Dementia; Cognition; Family Caregivers; Health Related Quality of Life; Dyadic Intervention
• Intervention / Treatment: Behavioral: Dyadic empowerment-based sport stacking; Other: Basic education

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Ziying Yang; Phone Number: +86 15858807566; Email: ziying1@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyadic empowerment-based sport stacking group	Behavioral: 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.
Active Comparator: Basic education group	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory function	The Auditory Verbal Learning Task (AVLT) will be used to assess their memory.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Processing speed and executive function	The Trail-Making Test (TMT) will be used to assess cognitive processing speed and executive function.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Burden	The 22-item Zarit burden interview (ZBI, Chinese version) will be used to assess caregivers' burden.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Compliance rate in sport stacking	Frequency of dyadic practice and total time will be used to evaluate completion status in sport stacking program.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Behavioral and psychological symptoms of dementia	The Neuropsychiatric Inventory (NPI), which was administered to the caregiver, will be utilized to assess the presence and severity of 12 common behavioral and psychological symptoms of dementia. The sum scores range from 0 to 144, with higher scores representing more severe neuropsychiatric behavioral symptoms.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Expressed emotion	The 30-item Family Attitude Scale Chinese version (FAS-C) will be used to measure caregivers' expressed emotion. The sum scores range from 0 to 120, with a higher score representing higher levels of expressed emotion.	baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: UW 24-395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in dementia. The data will be shared until after publication. The data may be shared through a file that requires a password for access. The personal information of participants has already been replaced with a unique case ID to ensure confidentiality and protect their privacy.
• IPD Sharing 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.
• IPD Sharing 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No