Effects of the Buddy-Up Dyadic Physical Activity Program on Health Outcomes of Care Dyads of Dementia: A Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of the Buddy-Up Dyadic Physical Activity (BUDPA) Program on the Health Outcomes of Care Dyads of Dementia: A Pilot Feasibility Study

Conditions
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Mild Dementia, Moderate Dementia

Intervention / Treatment
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* Behavioral: BUDPA Program
* Other: Control arm (Usual care)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUDPA Program<br>The overall program includes 12 weekly 1-hour training class. Each session starts with a 10-minute warm-up period using stretching exercise and stationary mobilizing exercise for trunk and limb joints at both upper and lower bodies and followed by a session of four to six selected partnering exercise, with duration increase gradually from 20 minutes to 40 minutes in four weeks' time. The Borg Rate of Perceived Exertion (Borg RPE) will be used to monitor the exercise intensity. The research assistant will explain the Borg RPE scale to the subjects and instruct them to speed up or slow down their movements in order to achieve a feeling of 'somewhat hard' at the Borg RPE rating of 12-14. The training session will end with a 10-minute cool down exercise session. | Behavioral: BUDPA Program<br>* The overall program includes 12 weekly 1-hour training class. Each session starts with a 10-minute warm-up period using stretching exercise and stationary mobilizing exercise for trunk and limb joints at both upper and lower bodies (e.g. shoulders, elbows, wrists, hips, knees and ankles), and followed by a session of four to six selected partnering exercise, with duration increase gradually from 20 minutes to 40minutes in four weeks' time. The Borg Rate of Perceived Exertion (Borg RPE) will be used to monitor the exercise intensity. The Research assistant will explain the Borg RPE scale to the subjects and instruct them to speed up or slow down their movements. The training session will end with a 10-minute cool down session with walking exercise and stationary trunk and limb mobilizing exercise involving joints of shoulders, elbows, wrists, hips, knees, and ankles.<br>|
| Active Comparator: Usual Care<br>Activities will be provided by the elderly community center such as dementia or caregiver supporting service. They will be allowed to use the regular service provided such services are not related to physical activity or exercise training. | Other: Control arm (Usual care)<br>* Active Comparator: Usual Care Activities will be provided by the elderly community center such as dementia or caregiver supporting service. They will be allowed to use the regular service provided such services are not related to physical activity or exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD | Baseline | 
| Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD | 6th week | 
| Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD | 12th week | 
| Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD | 18th week | 
| Zarit Burden Interview (Chinese version; ZBI-C) | measuring the caregiving burden of the family caregivers | Baseline | 
| Zarit Burden Interview (Chinese version; ZBI-C) | measuring the caregiving burden of the family caregivers | 6th week | 
| Zarit Burden Interview (Chinese version; ZBI-C) | measuring the caregiving burden of the family caregivers | 12th week | 
| Zarit Burden Interview (Chinese version; ZBI-C) | measuring the caregiving burden of the family caregivers | 18th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-psychiatric Inventory (CNPI; Chinese version) | Evaluating neuro-psychiatric symptoms of the PwD | Baseline | 
| Neuro-psychiatric Inventory (CNPI; Chinese version) | Evaluating neuro-psychiatric symptoms of the PwD | 6th week | 
| Neuro-psychiatric Inventory (CNPI; Chinese version) | Evaluating neuro-psychiatric symptoms of the PwD | 12th week | 
| Neuro-psychiatric Inventory (CNPI; Chinese version) | Evaluating neuro-psychiatric symptoms of the PwD | 18th week | 
| Lawton Instrumental activities of daily living IADL(IADL) Questionnaire | Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd | Baseline | 
| Lawton Instrumental activities of daily living IADL(IADL) Questionnaire | Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd | 6th week | 
| Lawton Instrumental activities of daily living IADL(IADL) Questionnaire | Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd | 12th week | 
| Lawton Instrumental activities of daily living IADL(IADL) Questionnaire | Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd | 18th week | 
| Profile of Mood State (Abbreviated) | Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers | Baseline | 
| Profile of Mood State (Abbreviated) | Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers | 6th week | 
| Profile of Mood State (Abbreviated) | Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers | 12th week | 
| Profile of Mood State (Abbreviated) | Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers | 18th week | 
| Positive Affect Index | Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection. | Baseline | 
| Positive Affect Index | Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection. | 6th week | 
| Positive Affect Index | Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection. | 12th week | 
| Positive Affect Index | Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection. | 18th week | 
| Positive Aspects of Caregiving Scale | To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life. | Baseline | 
| Positive Aspects of Caregiving Scale | To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life. | 6th week | 
| Positive Aspects of Caregiving Scale | To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life. | 12th week | 
| Positive Aspects of Caregiving Scale | To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life. | 18th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to early moderate dementia