Clinical trial NCT06584110: Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Official title: Effects of Buddy-Up Dyadic Physical Activity Program on Health Outcomes and Social Dynamic of Persons With Dementia and Family Caregivers: A Mixed Method Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment, Mild
Dementia, Mild
Keywords: dementia
dyads exercise
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.

i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.

ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-minutes debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.

iii) Habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
Primary purpose: TREATMENT

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 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 study aims to examine whether a 16-week theory-based partner exercise, named as Buddy-Up Dyadic Physical Activity (BUDPA) program, can improve dyadic dynamics and health outcomes of care dyads of mild to early-moderate dementia.

This sequential mixed-method study will recruit 111 care dyads from the elderly centers in Hong Kong. They will be randomized to receive the enhanced BUDPA program or usual care. The changes in the dyadic dynamics and health outcomes \[including symptom severity and health-related quality of life (HRQL) of persons with dementia; and affect, positive aspects of caregiving and HRQL of family caregivers\] between the two study groups from baseline (T0) to 16-weeks after baseline (T1) upon completion of the training , and at 24-weeks after baseline (T2). Data from outcome evaluation and interviews will be integrated to solicit a thorough understanding on the impact of BUDPA. This study marks the first attempt to use theory-driven dyadic intervention to enhance the dyadic dynamics and health outcomes of dementia care dyads. The project will advance the dyadic science in a dementia caregiving context and inform the development of evidence-based care model in dyadic fashion to promote living well with dementia in a caregiving context.

Detailed description: 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 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 study aims to examine whether a 16-week theory-based partner exercise, named as Buddy-Up Dyadic Physical Activity (BUDPA) program, can improve dyadic dynamics and health outcomes of care dyads of mild to early-moderate dementia.

This sequential mixed-method study will recruit 112 care dyads (people with Dementia (PwD) and family caregivers) from the elderly centers in Hong Kong. They will be randomized to receive the enhanced BUDPA program or usual care.

Subject:

For people with Dementia (PwD), the inclusion criteria are i) confirmed diagnosed of dementia ii) cognitive impairment as indicated by a Hong Kong-Montreal Cognitive Assessment (Hong Kong version; HK-MoCA) score of 8-19 to indicate mild to early moderate dementia will be recruited For family caregivers, the inclusion criteria are i) live together with the PwD ii) identify as the primary family caregivers of the PwD

The changes in the dyadic dynamics and health outcomes \[including symptom severity and health-related quality of life (HRQL) of persons with dementia; and affect, positive aspects of caregiving and HRQL of family caregivers\] between the two study groups from baseline (T0) to 16-weeks after baseline (T1) upon completion of the training , and at 24-weeks after baseline (T2).

1. For Pwd, 4 scales will be used, Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog), Color-Trails Test , Quality of Life-Alzheimer's Disease(QoL-AD), and The Dyadic Relationship Scale.
2. For family caregivers, measures the The Zarit Burden Interview (ZBI-C), The Neuro-psychiatric Inventory (NPI), The International Positive and Negative Affect Schedule - Short-Form (PANAS-SF 20 affect state), Medical Outcomes Study Short Form Health Survey (SF-12), The Dyadic Relationship Scale, and Positive Aspect of Caregiving Scale (PAC).

BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.

i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.

ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-min debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.

iii) habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.

Data from outcome evaluation and interviews will be integrated to solicit a thorough understanding on the impact of BUDPA. This study marks the first attempt to use theory-driven dyadic intervention to enhance the dyadic dynamics and health outcomes of dementia care dyads. The project will advance the dyadic science in a dementia caregiving context and inform the development of evidence-based care model in dyadic fashion to promote living well with dementia in a caregiving context.

Eligibility criteria: Inclusion Criteria for people with dementia (PwD):

* confirmed diagnosis of dementia
* HK-MoCA score of 8-19 to indicate mild to early moderate dementia

Inclusion Criteria for family caregivers:

* live with the PwD in the same household
* self-identified as the primary family caregiver of the PwD

Exclusion Criteria for people with dementia (PwD):

* engaging in \&gt; 60 minutes per week of moderate or more vigorous exercise in the previous six months
* acute muscular-skeletal problems, stroke or cardio-respiratory disease

Inclusion Criteria for family caregivers:

* not self-identified as the primary family caregiver of the PwD

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
timeFrame: baseline (T0)
measure: Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
timeFrame: 16-weeks (T1) after baseline
measure: Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
timeFrame: 24-weeks (T2) after baseline
measure: Quality of Life-Alzheimer's Disease (QoL-AD)
timeFrame: baseline (T0)
measure: Quality of Life-Alzheimer's Disease (QoL-AD)
timeFrame: 16-weeks (T1) after baseline
measure: Quality of Life-Alzheimer's Disease (QoL-AD)
timeFrame: 24-weeks (T2) after baseline
measure: The Neuro-psychiatric Inventory (NPI)
timeFrame: baseline (T0)
measure: The Neuro-psychiatric Inventory (NPI)
timeFrame: 16-weeks (T1) after baseline
measure: The Neuro-psychiatric Inventory (NPI)
timeFrame: 24-weeks (T2) after baseline
measure: The Zarit Burden Interview (ZBI)
timeFrame: baseline (T0)
measure: The Zarit Burden Interview (ZBI)
timeFrame: 16-weeks (T1) after baseline
measure: The Zarit Burden Interview (ZBI)
timeFrame: 24-weeks (T2) after baseline
measure: The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
timeFrame: baseline (T0)
measure: The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
timeFrame: 16-weeks (T1) after baseline
measure: The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
timeFrame: 24-weeks (T2) after baseline
measure: The Color-Trails Test (CTT)
timeFrame: baseline (T0)
measure: The Color-Trails Test (CTT)
timeFrame: 16-weeks (T1) after baseline
measure: The Color-Trails Test (CTT)
timeFrame: 24-weeks (T2) after baseline
measure: The digit span-forward and backward test
timeFrame: baseline (T0)
measure: The digit span-forward and backward test
timeFrame: 16-weeks (T1) after baseline
measure: The digit span-forward and backward test
timeFrame: 24-weeks (T2) after baseline
Secondary outcomes:
measure: Medical Outcomes Study Short Form Health Survey (SF-12)
timeFrame: baseline (T0)
measure: Medical Outcomes Study Short Form Health Survey (SF-12)
timeFrame: 16-weeks (T1) after baseline
measure: Medical Outcomes Study Short Form Health Survey (SF-12)
timeFrame: 24-weeks (T2) after baseline
measure: The Dyadic Relationship Scale (DRS)
timeFrame: baseline (T0)
measure: The Dyadic Relationship Scale (DRS)
timeFrame: 16-weeks (T1) after baseline
measure: The Dyadic Relationship Scale (DRS)
timeFrame: 24-weeks (T2) after baseline
measure: Positive Aspect of Caregiving Scale (PAC)
timeFrame: baseline (T0)
measure: Positive Aspect of Caregiving Scale (PAC)
timeFrame: 16-weeks (T1) after baseline
measure: Positive Aspect of Caregiving Scale (PAC)
timeFrame: 24-weeks (T2) after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
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