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

November 27, 2023 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Doris, Sau Fung YU, PhD
  • Phone Number: +852 39176319
  • Email: dyu1@hku.hk

Study Contact Backup

  • Name: Wai Man Fu, BSocSc
  • Phone Number: +852 39176657
  • Email: po170617@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, LKS Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BUDPA Program
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
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.
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.
Other: Control arm (Usual care)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
6th week
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
12th week
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
18th week
Zarit Burden Interview (Chinese version; ZBI-C)
Time Frame: Baseline
measuring the caregiving burden of the family caregivers
Baseline
Zarit Burden Interview (Chinese version; ZBI-C)
Time Frame: 6th week
measuring the caregiving burden of the family caregivers
6th week
Zarit Burden Interview (Chinese version; ZBI-C)
Time Frame: 12th week
measuring the caregiving burden of the family caregivers
12th week
Zarit Burden Interview (Chinese version; ZBI-C)
Time Frame: 18th week
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)
Time Frame: Baseline
Evaluating neuro-psychiatric symptoms of the PwD
Baseline
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time Frame: 6th week
Evaluating neuro-psychiatric symptoms of the PwD
6th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time Frame: 12th week
Evaluating neuro-psychiatric symptoms of the PwD
12th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time Frame: 18th week
Evaluating neuro-psychiatric symptoms of the PwD
18th week
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
Baseline
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
6th week
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
12th week
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
18th week
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
Baseline
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
6th week
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
12th week
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
18th week
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.
Baseline
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.
6th week
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.
12th week
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.
18th week
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.
Baseline
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.
6th week
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.
12th week
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.
18th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Doris, Sau Fung YU, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUDPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only study investigators and research assistants involved in the study will have access to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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