Cognitive Impairment, MildBUDPANCT06584110
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
A study testing Buddy-Up Dyadic Physical Activity (BUDPA) program in people with Cognitive Impairment, Mild and Dementia, Mild, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Mild, Dementia, Mild, Dementia
- What is being tested?
- Buddy-Up Dyadic Physical Activity (BUDPA) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Doris Sau Fung Yu, PhD, +852 3917 6319, dyu1@hku.hk
About this study
Official title: 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.
Read more
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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.
Read the 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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- 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.
- 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.
- Conditions
- Cognitive Impairment, Mild, Dementia, Mild, Dementia, Caregiver Burden
- Being tested
- Buddy-Up Dyadic Physical Activity (BUDPA) program, Usual care with waitlist control
- Keywords
- dementia, dyads exercise, cognitive impairment, caregiver
- Medical subject headings
- Cognitive Dysfunction, Dementia, Lymphoma, Follicular, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buddy-Up Dyadic Physical Activity (BUDPA) programOther
Also called BUDPA
BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.
- 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.
Usual care with waitlist controlOther
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
| Study group | Role | What they receive |
|---|---|---|
| BUDPA program | Experimental | 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. Receives: Other: Buddy-Up Dyadic Physical Activity (BUDPA) program |
| Usual care with waitlist control | Other | 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 Receives: Other: Usual care with waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Measured: 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)
evaluate caregiver's mood status, scales from 20 to 100, with higher score indicating higher mood change
Measured: 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)
evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.
Measured: 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
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
Measured: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
Secondary outcomes (6)
Medical Outcomes Study Short Form Health Survey (SF-12)
evaluates the health-related quality of life (HRQL) of the family caregiver, scales from 12 to 60, with higher score indicating better HRQL
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
evaluate the perceived caregiving burden among the caregivers, scales from 0 to 88, with higher score indicating higher perceived burden of caregivers
Measured: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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-minutes 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- SAU FUNG DORIS YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584110
- Sponsor's protocol ID
- BUDPA-RCT
- Acronym
- BUDPA
- Status last verified
- Mar 2026
- First submitted
- 31 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Publications
Liu JD, You RH, Liu H, Chung PK. Chinese version of the international positive and negative affect schedule short form: factor structure and measurement invariance. Health Qual Life Outcomes. 2020 Aug 24;18(1):285. doi: 10.1186/s12955-020-01526-6.
PubMed 32838809Martin M, Peter-Wight M, Braun M, Hornung R, Scholz U. The 3-phase-model of dyadic adaptation to dementia: why it might sometimes be better to be worse. Eur J Ageing. 2009 Sep 29;6(4):291. doi: 10.1007/s10433-009-0129-5. eCollection 2009 Dec.
PubMed 28798612Laver K, Milte R, Dyer S, Crotty M. A Systematic Review and Meta-Analysis Comparing Carer Focused and Dyadic Multicomponent Interventions for Carers of People With Dementia. J Aging Health. 2017 Dec;29(8):1308-1349. doi: 10.1177/0898264316660414. Epub 2016 Jul 25.
PubMed 27458254Fauth E, Hess K, Piercy K, Norton M, Corcoran C, Rabins P, Lyketsos C, Tschanz J. Caregivers' relationship closeness with the person with dementia predicts both positive and negative outcomes for caregivers' physical health and psychological well-being. Aging Ment Health. 2012;16(6):699-711. doi: 10.1080/13607863.2012.678482.
PubMed 22548375Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14.
PubMed 23097740Dassel 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.
PubMed 25161263Stall NM, Kim SJ, Hardacre KA, Shah PS, Straus SE, Bronskill SE, Lix LM, Bell CM, Rochon PA. Association of Informal Caregiver Distress with Health Outcomes of Community-Dwelling Dementia Care Recipients: A Systematic Review. J Am Geriatr Soc. 2019 Mar;67(3):609-617. doi: 10.1111/jgs.15690. Epub 2018 Dec 10.
PubMed 30536383Law CK, Lam FM, Chung RC, Pang MY. Physical exercise attenuates cognitive decline and reduces behavioural problems in people with mild cognitive impairment and dementia: a systematic review. J Physiother. 2020 Jan;66(1):9-18. doi: 10.1016/j.jphys.2019.11.014. Epub 2019 Dec 13.
PubMed 31843427Baik D, Song J, Tark A, Coats H, Shive N, Jankowski C. Effects of Physical Activity Programs on Health Outcomes of Family Caregivers of Older Adults with Chronic Diseases: A Systematic Review. Geriatr Nurs. 2021 Sep-Oct;42(5):1056-1069. doi: 10.1016/j.gerinurse.2021.06.018. Epub 2021 Jul 11.
PubMed 34261027Yu HM, He RL, Ai YM, Liang RF, Zhou LY. Reliability and validity of the quality of life-Alzheimer disease Chinese version. J Geriatr Psychiatry Neurol. 2013 Dec;26(4):230-6. doi: 10.1177/0891988713500586. Epub 2013 Aug 22.
PubMed 23970459Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.
PubMed 11536346Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
PubMed 18515696Moyle W, Jones C, Dwan T, Ownsworth T, Sung B. Using telepresence for social connection: views of older people with dementia, families, and health professionals from a mixed methods pilot study. Aging Ment Health. 2019 Dec;23(12):1643-1650. doi: 10.1080/13607863.2018.1509297. Epub 2018 Nov 17.
PubMed 30450924Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
PubMed 15892443Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
PubMed 18192628
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06584110
- Acronym / sponsor ID
- BUDPA / BUDPA-RCT
- Conditions
- Cognitive Impairment, Mild, Dementia, Mild, Dementia, Caregiver Burden
- Keywords
- dementia, dyads exercise, cognitive impairment, caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.
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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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-minutes 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.
| Arm | Type | Receives |
|---|---|---|
| BUDPA program | Experimental | Other: Buddy-Up Dyadic Physical Activity (BUDPA) programBUDPA 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. |
| Usual care with waitlist control | Other | Other: Usual care with waitlist controlThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buddy-Up Dyadic Physical Activity (BUDPA) programAlso: BUDPABUDPA 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 | BUDPA program |
| Usual care with waitlist controlThe 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 |
Primary outcome
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.
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
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.
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 32838809Liu JD, You RH, Liu H, Chung PK. Chinese version of the international positive and negative affect schedule short form: factor structure and measurement invariance. Health Qual Life Outcomes. 2020 Aug 24;18(1):285. doi: 10.1186/s12955-020-01526-6.
- Background: PubMed 28798612Martin M, Peter-Wight M, Braun M, Hornung R, Scholz U. The 3-phase-model of dyadic adaptation to dementia: why it might sometimes be better to be worse. Eur J Ageing. 2009 Sep 29;6(4):291. doi: 10.1007/s10433-009-0129-5. eCollection 2009 Dec.
- Background: PubMed 27458254Laver K, Milte R, Dyer S, Crotty M. A Systematic Review and Meta-Analysis Comparing Carer Focused and Dyadic Multicomponent Interventions for Carers of People With Dementia. J Aging Health. 2017 Dec;29(8):1308-1349. doi: 10.1177/0898264316660414. Epub 2016 Jul 25.
- Background: PubMed 22548375Fauth E, Hess K, Piercy K, Norton M, Corcoran C, Rabins P, Lyketsos C, Tschanz J. Caregivers' relationship closeness with the person with dementia predicts both positive and negative outcomes for caregivers' physical health and psychological well-being. Aging Ment Health. 2012;16(6):699-711. doi: 10.1080/13607863.2012.678482.
- Background: PubMed 23097740Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14.
- Background: PubMed 25161263Dassel 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.
- Background: PubMed 30536383Stall NM, Kim SJ, Hardacre KA, Shah PS, Straus SE, Bronskill SE, Lix LM, Bell CM, Rochon PA. Association of Informal Caregiver Distress with Health Outcomes of Community-Dwelling Dementia Care Recipients: A Systematic Review. J Am Geriatr Soc. 2019 Mar;67(3):609-617. doi: 10.1111/jgs.15690. Epub 2018 Dec 10.
- Background: PubMed 31843427Law CK, Lam FM, Chung RC, Pang MY. Physical exercise attenuates cognitive decline and reduces behavioural problems in people with mild cognitive impairment and dementia: a systematic review. J Physiother. 2020 Jan;66(1):9-18. doi: 10.1016/j.jphys.2019.11.014. Epub 2019 Dec 13.
- Background: PubMed 34261027Baik D, Song J, Tark A, Coats H, Shive N, Jankowski C. Effects of Physical Activity Programs on Health Outcomes of Family Caregivers of Older Adults with Chronic Diseases: A Systematic Review. Geriatr Nurs. 2021 Sep-Oct;42(5):1056-1069. doi: 10.1016/j.gerinurse.2021.06.018. Epub 2021 Jul 11.
- Background: PubMed 23970459Yu HM, He RL, Ai YM, Liang RF, Zhou LY. Reliability and validity of the quality of life-Alzheimer disease Chinese version. J Geriatr Psychiatry Neurol. 2013 Dec;26(4):230-6. doi: 10.1177/0891988713500586. Epub 2013 Aug 22.
- Background: PubMed 11536346Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.
- Background: PubMed 18515696Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
Related trials for Cognitive Impairment, Mild
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SAU FUNG DORIS YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buddy-Up Dyadic Physical Activity (BUDPA) program in people with Cognitive Impairment, Mild and Dementia, Mild, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAU FUNG DORIS YU, PhD (852-39176319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06584110, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.