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

Primary Purpose

Mild Dementia, Moderate Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
BUDPA Program
Control arm (Usual care)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Dementia focused on measuring mild to early moderate dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Nursing, LKS Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BUDPA Program

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers

Secondary Outcome Measures

Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
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
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
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
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
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.

Full Information

First Posted
April 16, 2021
Last Updated
May 30, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04913818
Brief Title
Effects of the Buddy-Up Dyadic Physical Activity Program on Health Outcomes of Care Dyads of Dementia: A Pilot Study
Acronym
BUDPA
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Dementia, Moderate Dementia
Keywords
mild to early moderate dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BUDPA Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BUDPA Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control arm (Usual care)
Intervention Description
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 Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD
Time Frame
Baseline
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD
Time Frame
6th week
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD
Time Frame
12th week
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD
Time Frame
18th week
Title
Zarit Burden Interview (Chinese version; ZBI-C)
Description
measuring the caregiving burden of the family caregivers
Time Frame
Baseline
Title
Zarit Burden Interview (Chinese version; ZBI-C)
Description
measuring the caregiving burden of the family caregivers
Time Frame
6th week
Title
Zarit Burden Interview (Chinese version; ZBI-C)
Description
measuring the caregiving burden of the family caregivers
Time Frame
12th week
Title
Zarit Burden Interview (Chinese version; ZBI-C)
Description
measuring the caregiving burden of the family caregivers
Time Frame
18th week
Secondary Outcome Measure Information:
Title
Neuro-psychiatric Inventory (CNPI; Chinese version)
Description
Evaluating neuro-psychiatric symptoms of the PwD
Time Frame
Baseline
Title
Neuro-psychiatric Inventory (CNPI; Chinese version)
Description
Evaluating neuro-psychiatric symptoms of the PwD
Time Frame
6th week
Title
Neuro-psychiatric Inventory (CNPI; Chinese version)
Description
Evaluating neuro-psychiatric symptoms of the PwD
Time Frame
12th week
Title
Neuro-psychiatric Inventory (CNPI; Chinese version)
Description
Evaluating neuro-psychiatric symptoms of the PwD
Time Frame
18th week
Title
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Description
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Time Frame
Baseline
Title
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Description
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Time Frame
6th week
Title
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Description
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Time Frame
12th week
Title
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Description
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Time Frame
18th week
Title
Profile of Mood State (Abbreviated)
Description
Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers
Time Frame
Baseline
Title
Profile of Mood State (Abbreviated)
Description
Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers
Time Frame
6th week
Title
Profile of Mood State (Abbreviated)
Description
Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers
Time Frame
12th week
Title
Profile of Mood State (Abbreviated)
Description
Measuring the six identifiable mood status including tension anxiety, depression dejection, anger hostility, vigor activity, fatigue inertia and confusion bewilderment of family caregivers
Time Frame
18th week
Title
Positive Affect Index
Description
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Time Frame
Baseline
Title
Positive Affect Index
Description
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Time Frame
6th week
Title
Positive Affect Index
Description
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Time Frame
12th week
Title
Positive Affect Index
Description
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Time Frame
18th week
Title
Positive Aspects of Caregiving Scale
Description
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Time Frame
Baseline
Title
Positive Aspects of Caregiving Scale
Description
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Time Frame
6th week
Title
Positive Aspects of Caregiving Scale
Description
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Time Frame
12th week
Title
Positive Aspects of Caregiving Scale
Description
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Time Frame
18th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris, Sau Fung YU, PhD
Phone
+852 39176319
Email
dyu1@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Man Fu, BSocSc
Phone
+852 39176657
Email
po170617@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris, Sau Fung YU, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, LKS Faculty of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only study investigators and research assistants involved in the study will have access to the data.
Citations:
PubMed Identifier
25161263
Citation
Dassel KB, Carr DC. Does Dementia Caregiving Accelerate Frailty? Findings From the Health and Retirement Study. Gerontologist. 2016 Jun;56(3):444-50. doi: 10.1093/geront/gnu078. Epub 2014 Aug 26.
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Van't Leven N, Prick AE, Groenewoud JG, Roelofs PD, de Lange J, Pot AM. Dyadic interventions for community-dwelling people with dementia and their family caregivers: a systematic review. Int Psychogeriatr. 2013 Oct;25(10):1581-603. doi: 10.1017/S1041610213000860. Epub 2013 Jul 24.
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Links:
URL
https://www.alz.co.uk/research/world-report-2015
Description
Alzheimer's Disease International. World Alzheimer Report-2015
URL
https://www.alz.co.uk/research/world-report-2016
Description
Alzheimer's Disease International. World Alzheimer Report-2016
URL
http://www.cdc.gov/physicalactivity/everyone/measuring/exertion.html
Description
Centers for Disease Control and Prevention. Perceived exertion (Borg Rating of Perceived Exertion Scale)

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

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