Mild DementiaBUDPANCT04913818
Effects of the Buddy-Up Dyadic Physical Activity Program on Health Outcomes of Care Dyads of Dementia: A Pilot Study
A study testing BUDPA Program in people with Mild Dementia and Moderate Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Dementia, Moderate Dementia
- What is being tested?
- BUDPA Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jun 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mild Dementia, Moderate Dementia
- Being tested
- BUDPA Program, Control arm (Usual care)
- Keywords
- mild to early moderate dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUDPA ProgramBehavioural
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.
Control arm (Usual care)Other
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
| Study group | Role | What they receive |
|---|---|---|
| BUDPA Program | Experimental | 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. Receives: Behavioral: BUDPA Program |
| Usual Care | Active comparator | 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. Receives: Other: Control arm (Usual care) |
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)
evaluating various domains (i.e. attention and working memory, episodic memory, complex attention, executive function and task switching) of cognition of the PwD
Measured: Baseline
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
Measured: 6th week
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
Measured: 12th week
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
Measured: 18th week
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Measured: Baseline
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Measured: 6th week
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Measured: 12th week
Zarit Burden Interview (Chinese version; ZBI-C)
measuring the caregiving burden of the family caregivers
Measured: 18th week
Secondary outcomes (20)
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Measured: Baseline
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Measured: 6th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Measured: 12th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Evaluating neuro-psychiatric symptoms of the PwD
Measured: 18th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Measured: Baseline
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Measured: 6th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Measured: 12th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd
Measured: 18th week
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
Measured: Baseline
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
Measured: 6th week
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
Measured: 12th week
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
Measured: 18th week
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Measured: Baseline
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Measured: 6th week
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Measured: 12th week
Positive Affect Index
Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.
Measured: 18th week
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Measured: Baseline
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Measured: 6th week
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Measured: 12th week
Positive Aspects of Caregiving Scale
To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.
Measured: 18th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start5 Jun 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mild DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
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
- Doris, Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913818
- Sponsor's protocol ID
- BUDPA
- Acronym
- BUDPA
- Status last verified
- Nov 2023
- First submitted
- 16 Apr 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study investigators and research assistants involved in the study will have access to the data.
Publications
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.
PubMed 25161263Van'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.
PubMed 23883489Yu DSF, Cheng ST, Wang J. Unravelling positive aspects of caregiving in dementia: An integrative review of research literature. Int J Nurs Stud. 2018 Mar;79:1-26. doi: 10.1016/j.ijnurstu.2017.10.008. Epub 2017 Oct 16.
PubMed 29128685Hernandez SS, Sandreschi PF, da Silva FC, Arancibia BA, da Silva R, Gutierres PJ, Andrade A. What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. J Aging Phys Act. 2015 Oct;23(4):659-68. doi: 10.1123/japa.2014-0180. Epub 2014 Nov 21.
PubMed 25414947Puterman E, Weiss J, Lin J, Schilf S, Slusher AL, Johansen KL, Epel ES. Aerobic exercise lengthens telomeres and reduces stress in family caregivers: A randomized controlled trial - Curt Richter Award Paper 2018. Psychoneuroendocrinology. 2018 Dec;98:245-252. doi: 10.1016/j.psyneuen.2018.08.002. Epub 2018 Aug 2.
PubMed 30266522Prick AE, de Lange J, Scherder E, Twisk J, Pot AM. The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia: a randomized controlled trial. Clin Interv Aging. 2016 Mar 31;11:383-95. doi: 10.2147/CIA.S95789. eCollection 2016.
PubMed 27099480Gellert P, Ziegelmann JP, Warner LM, Schwarzer R. Physical activity intervention in older adults: does a participating partner make a difference? Eur J Ageing. 2011 Jul 7;8(3):211. doi: 10.1007/s10433-011-0193-5. eCollection 2011 Sep.
PubMed 28798651Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
PubMed 25125421American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PubMed 19516148Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.
PubMed 11056778Leung 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 18515696Chen KM, Snyder M, Krichbaum K. Translation and equivalence: the Profile of Mood States Short Form in English and Chinese. Int J Nurs Stud. 2002 Aug;39(6):619-24. doi: 10.1016/s0020-7489(01)00068-2.
PubMed 12100873Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
PubMed 25488014
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04913818
- Acronym / sponsor ID
- BUDPA / BUDPA
- Conditions
- Mild Dementia, Moderate Dementia
- Keywords
- mild to early moderate dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 4 Jun 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| BUDPA Program | Experimental | Behavioral: BUDPA ProgramThe 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. |
| Usual Care | Active comparator | Other: Control arm (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| BUDPA ProgramThe 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. | Behavioural | BUDPA Program |
| 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 | Other | Usual Care |
Primary outcome
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
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
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
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
Zarit Burden Interview (Chinese version; ZBI-C)
Time frame: Baseline
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
Time frame: 6th week
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
Time frame: 12th week
measuring the caregiving burden of the family caregivers
Zarit Burden Interview (Chinese version; ZBI-C)
Time frame: 18th week
measuring the caregiving burden of the family caregivers
20 secondary outcomes
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time frame: Baseline
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time frame: 6th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time frame: 12th week
Neuro-psychiatric Inventory (CNPI; Chinese version)
Time frame: 18th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Time frame: Baseline
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Time frame: 6th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Time frame: 12th week
Lawton Instrumental activities of daily living IADL(IADL) Questionnaire
Time frame: 18th week
Profile of Mood State (Abbreviated)
Time frame: Baseline
Profile of Mood State (Abbreviated)
Time frame: 6th week
Profile of Mood State (Abbreviated)
Time frame: 12th week
Profile of Mood State (Abbreviated)
Time frame: 18th week
Positive Affect Index
Time frame: Baseline
Positive Affect Index
Time frame: 6th week
Positive Affect Index
Time frame: 12th week
Positive Affect Index
Time frame: 18th week
Positive Aspects of Caregiving Scale
Time frame: Baseline
Positive Aspects of Caregiving Scale
Time frame: 6th week
Positive Aspects of Caregiving Scale
Time frame: 12th week
Positive Aspects of Caregiving Scale
Time frame: 18th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- 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 23883489Van'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.
- Background: PubMed 29128685Yu DSF, Cheng ST, Wang J. Unravelling positive aspects of caregiving in dementia: An integrative review of research literature. Int J Nurs Stud. 2018 Mar;79:1-26. doi: 10.1016/j.ijnurstu.2017.10.008. Epub 2017 Oct 16.
- Background: PubMed 25414947Hernandez SS, Sandreschi PF, da Silva FC, Arancibia BA, da Silva R, Gutierres PJ, Andrade A. What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. J Aging Phys Act. 2015 Oct;23(4):659-68. doi: 10.1123/japa.2014-0180. Epub 2014 Nov 21.
- Background: PubMed 30266522Puterman E, Weiss J, Lin J, Schilf S, Slusher AL, Johansen KL, Epel ES. Aerobic exercise lengthens telomeres and reduces stress in family caregivers: A randomized controlled trial - Curt Richter Award Paper 2018. Psychoneuroendocrinology. 2018 Dec;98:245-252. doi: 10.1016/j.psyneuen.2018.08.002. Epub 2018 Aug 2.
- Background: PubMed 27099480Prick AE, de Lange J, Scherder E, Twisk J, Pot AM. The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia: a randomized controlled trial. Clin Interv Aging. 2016 Mar 31;11:383-95. doi: 10.2147/CIA.S95789. eCollection 2016.
- Background: PubMed 28798651Gellert P, Ziegelmann JP, Warner LM, Schwarzer R. Physical activity intervention in older adults: does a participating partner make a difference? Eur J Ageing. 2011 Jul 7;8(3):211. doi: 10.1007/s10433-011-0193-5. eCollection 2011 Sep.
- Background: PubMed 25125421Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
- Background: PubMed 19516148American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
- Background: PubMed 11056778Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.
- 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.
- Alzheimer's Disease International. World Alzheimer Report-2015Link provided by the sponsor.
- Alzheimer's Disease International. World Alzheimer Report-2016Link provided by the sponsor.
- World Health Organization. Dementia: A public health priorityLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only study investigators and research assistants involved in the study will have access to the data.
Related trials for Mild Dementia
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Not yet recruitingPhase 3
Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
Alzheimer Disease
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
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. This study is not recruiting at the moment.
Doris, Sau Fung 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 BUDPA Program in people with Mild Dementia and Moderate Dementia, 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?
The sponsor lists 6 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 30 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). The study lists 8 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 NCT04913818, which also lists 14 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 30 Nov 2023.