NCT06584110 Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
| NCT ID | NCT06584110 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Cognitive Impairment, Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2024-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The global cost of dementia is over 818 billion, and a further rise is expected in the next decade. While family caregiving is the backbone of the formal care service, promoting "living well with dementia" needs to extend to a dyadic perspective to address the needs of persons with dementia (PwD) and their caregivers. Unique to dementia caregiving, imbalanced exchange in the assistance, interaction, relationship and autonomy between the partners in a care dyad always challenges their social interaction and relationships. Such eroding dyadic dynamics not only worsens the mental health of caregivers, but also compromises the quality of caregiving, fosters more dementia deterioration, and eventually complicates the caregiving process. Nevertheless, least attention is directed to dyadic dynamics in promoting living well with dementia. Partner exercise is designed in a way which requires collaboration of two members to enable the workout of each other. In addition to the benefits of exercise on dementia symptom control and caregiver's stress management, partner exercise provides a meaningful encounter to encourage reciprocity, collaboration and relationship closeness within the care dyad. This is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs. The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers (Objective 1-3). The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice (Objective 4). The primary outcomes include PwD's cognitive function and caregivers' mood status. We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in: 1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia. 2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers. 3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.
Eligibility Criteria
Eligibility for person with dementia (PwD) includes i) a confirmed diagnosis of dementia and ii) an HK-MoCA score of 8-19 to indicate mild to early moderate dementia. The caregivers will have to i) live with the participant with dementia ii) self-identify as the primary family caregiver iii) providing care for ≥ 4 hours/day iv) has a smartphone for FaceTime The exclusion criteria are i) engaging in ≥60 min/week of moderate or vigorous exercise in the past six months ii) having acute muscular-skeletal problems, cerebro-cardio-respiratory disease or condition contradictory to exercise training
Contact & Investigator
SAU FUNG DORIS YU, PhD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06584110 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Impairment, Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584110 currently recruiting?
Yes, NCT06584110 is actively recruiting participants. Contact the research team at dyu1@hku.hk for enrollment information.
Where is the NCT06584110 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06584110 clinical trial?
NCT06584110 is sponsored by The University of Hong Kong. The principal investigator is SAU FUNG DORIS YU, PhD at The University of Hong Kong. The trial plans to enroll 236 participants.