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Completed

NCT Number: NCT04913818

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

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.

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Key information

Conditions

Mild Dementia Moderate Dementia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, LKS Faculty of Medicine

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BUDPA Program

Behavioral

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.

Control arm (Usual care)

Other

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

Primary outcomes

  1. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    Time frame: Baseline

    evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD

  2. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    Time frame: 6th week

    evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD

  3. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    Time frame: 12th week

    evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD

  4. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    Time frame: 18th week

    evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD

  5. Zarit Burden Interview (Chinese version; ZBI-C)

    Time frame: Baseline

    measuring the caregiving burden of the family caregivers

  6. Zarit Burden Interview (Chinese version; ZBI-C)

    Time frame: 6th week

    measuring the caregiving burden of the family caregivers

  7. Zarit Burden Interview (Chinese version; ZBI-C)

    Time frame: 12th week

    measuring the caregiving burden of the family caregivers

  8. Zarit Burden Interview (Chinese version; ZBI-C)

    Time frame: 18th week

    measuring the caregiving burden of the family caregivers

Secondary outcomes

  1. Neuro-psychiatric Inventory (CNPI; Chinese version)

    Time frame: Baseline

    Evaluating neuro-psychiatric symptoms of the PwD

  2. Neuro-psychiatric Inventory (CNPI; Chinese version)

    Time frame: 6th week

    Evaluating neuro-psychiatric symptoms of the PwD

  3. Neuro-psychiatric Inventory (CNPI; Chinese version)

    Time frame: 12th week

    Evaluating neuro-psychiatric symptoms of the PwD

  4. Neuro-psychiatric Inventory (CNPI; Chinese version)

    Time frame: 18th week

    Evaluating neuro-psychiatric symptoms of the PwD

  5. Lawton Instrumental activities of daily living IADL(IADL) Questionnaire

    Time frame: Baseline

    Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd

  6. Lawton Instrumental activities of daily living IADL(IADL) Questionnaire

    Time frame: 6th week

    Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd

  7. Lawton Instrumental activities of daily living IADL(IADL) Questionnaire

    Time frame: 12th week

    Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd

  8. Lawton Instrumental activities of daily living IADL(IADL) Questionnaire

    Time frame: 18th week

    Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd

  9. Profile of Mood State (Abbreviated)

    Time frame: Baseline

    Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers

  10. Profile of Mood State (Abbreviated)

    Time frame: 6th week

    Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers

  11. Profile of Mood State (Abbreviated)

    Time frame: 12th week

    Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers

  12. Profile of Mood State (Abbreviated)

    Time frame: 18th week

    Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers

  13. Positive Affect Index

    Time frame: Baseline

    Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.

  14. Positive Affect Index

    Time frame: 6th week

    Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.

  15. Positive Affect Index

    Time frame: 12th week

    Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.

  16. Positive Affect Index

    Time frame: 18th week

    Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.

  17. Positive Aspects of Caregiving Scale

    Time frame: Baseline

    To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.

  18. Positive Aspects of Caregiving Scale

    Time frame: 6th week

    To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.

  19. Positive Aspects of Caregiving Scale

    Time frame: 12th week

    To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.

  20. Positive Aspects of Caregiving Scale

    Time frame: 18th week

    To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: BUDPA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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