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

NCT06584110 | Recruiting

• 1 other identifier: BUDPA-RCT
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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 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 study aims to examine whether a 16-week theory-based partner exercise, named as Buddy-Up Dyadic Physical Activity (BUDPA) program, can improve dyadic dynamics and health outcomes of care dyads of mild to early-moderate dementia. This sequential mixed-method study will recruit 111 care dyads from the elderly centers in Hong Kong. They will be randomized to receive the enhanced BUDPA program or usual care. The changes in the dyadic dynamics and health outcomes \[including symptom severity and health-related quality of life (HRQL) of persons with dementia; and affect, positive aspects of caregiving and HRQL of family caregivers\] between the two study groups from baseline (T0) to 16-weeks after baseline (T1) upon completion of the training , and at 24-weeks after baseline (T2). Data from outcome evaluation and interviews will be integrated to solicit a thorough understanding on the impact of BUDPA. This study marks the first attempt to use theory-driven dyadic intervention to enhance the dyadic dynamics and health outcomes of dementia care dyads. The project will advance the dyadic science in a dementia caregiving context and inform the development of evidence-based care model in dyadic fashion to promote living well with dementia in a caregiving context.

Conditions

Cognitive Impairment, Mild; Dementia, Mild

Keywords

dementia; dyads exercise

Outcome Measures

Primary Outcomes (21)

• 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.

  baseline (T0)

• 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.

  16-weeks (T1) after baseline

• 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.

  24-weeks (T2) after baseline

• 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

  baseline (T0)

• 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

  16-weeks (T1) after baseline

• 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

  24-weeks (T2) after baseline

• 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

  baseline (T0)

• 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

  16-weeks (T1) after baseline

• 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

  24-weeks (T2) after baseline

• 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

  baseline (T0)

• 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

  16-weeks (T1) after baseline

• 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

  24-weeks (T2) after baseline

• 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

  baseline (T0)

• 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

  16-weeks (T1) after baseline

• 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

  24-weeks (T2) after baseline

• The Color-Trails Test (CTT)

  evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.

  baseline (T0)

• The Color-Trails Test (CTT)

  evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.

  16-weeks (T1) after baseline

• The Color-Trails Test (CTT)

  evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.

  24-weeks (T2) after baseline

• 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

  baseline (T0)

• 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

  16-weeks (T1) after baseline

• 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

  24-weeks (T2) after baseline

Secondary Outcomes (9)

• Medical Outcomes Study Short Form Health Survey (SF-12)

  baseline (T0)

• Medical Outcomes Study Short Form Health Survey (SF-12)

  16-weeks (T1) after baseline

• Medical Outcomes Study Short Form Health Survey (SF-12)

  24-weeks (T2) after baseline

• The Dyadic Relationship Scale (DRS)

  baseline (T0)

• The Dyadic Relationship Scale (DRS)

  16-weeks (T1) after baseline

Study Arms (2)

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.

Other: Buddy-Up Dyadic Physical Activity (BUDPA) program

Usual care

PLACEBO COMPARATOR

Usual care will be provided in the elderly centres. Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.

Other: Usual care with waiting list

Interventions

Buddy-Up Dyadic Physical Activity (BUDPA) program OTHER

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.

Also known as: BUDPA

BUDPA program

Usual care with waiting list OTHER

Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of dementia
• HK-MoCA score of 8-19 to indicate mild to early moderate dementia
• live with the PwD in the same household
• self-identified as the primary family caregiver of the PwD

You may not qualify if:

• engaging in \> 60 minutes per week of moderate or more vigorous exercise in the previous six months
• acute muscular-skeletal problems, stroke or cardio-respiratory disease
• not self-identified as the primary family caregiver of the PwD

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (20)

• 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.

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• Martin 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.

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• Laver 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.

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• Fauth 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.

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• Yu 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.

  PMID: 23097740 BACKGROUND

• 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.

  PMID: 25161263 BACKGROUND

• Stall 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.

  PMID: 30536383 BACKGROUND

• Law 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.

  PMID: 31843427 BACKGROUND

• Baik 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.

  PMID: 34261027 BACKGROUND

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  PMID: 23970459 BACKGROUND

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  PMID: 11536346 BACKGROUND

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MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Lymphoma, Follicular

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

SAU FUNG DORIS YU, PhD

CONTACT

852-39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized into intervention group and wait-list control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: September 4, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)