Clinical trial NCT04913818: Effects of the Buddy-Up Dyadic Physical Activity Program on Health Outcomes of Care Dyads of Dementia: A Pilot Study
Official title: The Effects of the Buddy-Up Dyadic Physical Activity (BUDPA) Program on the Health Outcomes of Care Dyads of Dementia: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Dementia
Moderate Dementia
Keywords: mild to early moderate dementia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To examine the feasibility and preliminary effect of a partnering exercise program on the health outcomes of the PwD and their family caregivers
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project seeks to develop a novel dyadic intervention (titled as Buddy-Up Dyadic Physical Activity; BUDPA), using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers.

Detailed description: This project is a pilot study that seeks to develop a novel dyadic BUDPA intervention, using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers. BUDPA has integrated the concept of developing social capital for dementia management. By applying partner exercise, the longer-term provider for this therapeutic care will be shifted from service providers to the family caregivers and the persons with dementia. Helping them to translate the practice to a home-care setting further strengthens the notions of family responsibility and ability in dementia management. BUDPA fully engages the care dyads in a mutual helping relationship during the exercise training. The partner exercise also creates a platform to enable more meaningful encounter within the care dyad. The family caregivers are facilitated to find meaning in the caregiving process, which eventually can benefit their role commitment and mental wellness. Also, the use of mixed-method study design can provide high quality findings to inform both the feasibility and preliminary effects of the BUDPA program.

Eligibility criteria: Inclusion Criteria:

For PwD,

* confirmed diagnosed of mild to moderate-intensity dementia
* cognitive impairment as indicated by a HK-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

* live together with the PwD
* identify as the primary family caregivers of the PwD

Exclusion Criteria:

* engaging in \> 60 minutes per week of moderate or more vigorous exercise in the previous six months
* acute muscular-skeletal problem, stroke or cardio-respiratory disease.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
timeFrame: Baseline
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
timeFrame: 6th week
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
timeFrame: 12th week
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
timeFrame: 18th week
measure: Zarit Burden Interview (Chinese version; ZBI-C)
timeFrame: Baseline
measure: Zarit Burden Interview (Chinese version; ZBI-C)
timeFrame: 6th week
measure: Zarit Burden Interview (Chinese version; ZBI-C)
timeFrame: 12th week
measure: Zarit Burden Interview (Chinese version; ZBI-C)
timeFrame: 18th week
Secondary outcomes:
measure: Neuro-psychiatric Inventory (CNPI; Chinese version)
timeFrame: Baseline
measure: Neuro-psychiatric Inventory (CNPI; Chinese version)
timeFrame: 6th week
measure: Neuro-psychiatric Inventory (CNPI; Chinese version)
timeFrame: 12th week
measure: Neuro-psychiatric Inventory (CNPI; Chinese version)
timeFrame: 18th week
measure: Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
timeFrame: Baseline
measure: Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
timeFrame: 6th week
measure: Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
timeFrame: 12th week
measure: Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
timeFrame: 18th week
measure: Profile of Mood State (Abbreviated)
timeFrame: Baseline
measure: Profile of Mood State (Abbreviated)
timeFrame: 6th week
measure: Profile of Mood State (Abbreviated)
timeFrame: 12th week
measure: Profile of Mood State (Abbreviated)
timeFrame: 18th week
measure: Positive Affect Index
timeFrame: Baseline
measure: Positive Affect Index
timeFrame: 6th week
measure: Positive Affect Index
timeFrame: 12th week
measure: Positive Affect Index
timeFrame: 18th week
measure: Positive Aspects of Caregiving Scale
timeFrame: Baseline
measure: Positive Aspects of Caregiving Scale
timeFrame: 6th week
measure: Positive Aspects of Caregiving Scale
timeFrame: 12th week
measure: Positive Aspects of Caregiving Scale
timeFrame: 18th week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, LKS Faculty of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Doris, Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
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