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

March 31, 2026 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

Effects of Buddy-Up Dyadic Physical Activity Program on Health Outcomes and Social Dynamic of Persons With Dementia and Family Caregivers: A Mixed Method Randomized Controlled Trial

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 (PwD) 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 is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs.

The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers (Objective 1-3). The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice (Objective 4). The primary outcomes include PwD's cognitive function and caregivers' mood status.

We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in:

  1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
  2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
  3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (PwD) 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 is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs.

The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers. The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice. The primary outcomes include PwD's cognitive function and caregivers' mood status.

We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in:

  1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
  2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
  3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

This sequential mixed-method study will recruit 236 care dyads (including 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.

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.

Study Type

Interventional

Enrollment (Estimated)

236

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: SAU FUNG DORIS YU, PhD
  • Phone Number: 852-39176319
  • Email: dyu1@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Doris Sau Fung Yu, PhD
          • Phone Number: +852 3917 6319
          • Email: dyu1@hku.hk

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility for person with dementia (PwD) includes i) a confirmed diagnosis of dementia and ii) an HK-MoCA score of 8-19 to indicate mild to early moderate dementia.

The caregivers will have to i) live with the participant with dementia ii) self-identify as the primary family caregiver iii) providing care for ≥ 4 hours/day iv) has a smartphone for FaceTime

The exclusion criteria are i) engaging in ≥60 min/week of moderate or vigorous exercise in the past six months ii) having acute muscular-skeletal problems, cerebro-cardio-respiratory disease or condition contradictory to exercise training

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • BUDPA
Other: Usual care with waitlist control
The usual care such as dementia or caregiver support services, will be provided by the elderly community centres with a waitlist execute after the last assessment time point T3
Other: Usual care with waitlist control
The usual care such as dementia or caregiver support services, will be provided by the elderly community centres with a waitlist execute after the last assessment time point T3

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 (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate caregiver's mood status, scales from 20 to 100, with higher score indicating higher mood change
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The Color-Trails Test (CTT)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The digit span-forward and backward test
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Outcomes Study Short Form Health Survey (SF-12)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluates the health-related quality of life (HRQL) of the family caregiver, scales from 12 to 60, with higher score indicating better HRQL
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The Dyadic Relationship Scale (DRS)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the dyadic dynamic in terms of negative relationship strain and positive interaction within the care dyad, scales from 11 to 44, with higher score indicating higher levels of dyadic strain
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
Positive Aspect of Caregiving Scale (PAC)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate caregiver's gain in terms of self -affirmation and outlook on life, scales from 0 to 44, with higher scores indicating more positive caregiving gain
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
Quality of Life-Alzheimer's Disease (QoL-AD)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the health-related quality of life (HR) covering physical, functional, psychosocial, interpersonal, and environmental status of the patient with dementia, scales 13 to 52, with higher score indicating better HRQL
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The Neuro-psychiatric Inventory (NPI)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the neuro-psychiatric symptoms of the patient with dementia reported by the caregiver, scales from 12 to 96 with higher scores indicating higher severity
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
The Zarit Burden Interview (ZBI)
Time Frame: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the perceived caregiving burden among the caregivers, scales from 0 to 88, with higher score indicating higher perceived burden of caregivers
baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)

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: SAU FUNG DORIS 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

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)

October 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

September 1, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUDPA-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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