Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 > 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06584110
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Hong Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Hong Kong
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cognitive Impairment, Mild, Dementia, Mild
Additional Details

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.

Arms & Interventions

Arms

Experimental: BUDPA program

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.

Placebo Comparator: Usual care

Usual care will be provided in the elderly centres. Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.

Interventions

Other: - Buddy-Up Dyadic Physical Activity (BUDPA) program

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.

Other: - Usual care with waiting list

Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.

Contact a Trial Team

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International Sites

The University of Hong Kong, Hong Kong 1819729, Hong Kong

Status

Recruiting

Address

The University of Hong Kong

Hong Kong 1819729, ,

Site Contact

Doris Sau Fung Yu, PhD

[email protected]

+852 3917 6319

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