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

Mild Dementia Clinical Trial

— BUDPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913818
• Other study ID #: BUDPA
• Status: Completed
• Phase: N/A
• Start date: June 5, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For PwD,

• confirmed diagnosed of mild to moderate-intensity dementia

• cognitive impairment as indicated by a HK-Montreal Cognitive Assessment (Hong Kong version; HK-MoCA) score of 8-19 to indicate mild to early moderate dementia will be recruited

For family caregivers

• live together with the PwD

• identify as the primary family caregivers of the PwD

Exclusion Criteria:

• engaging in > 60 minutes per week of moderate or more vigorous exercise in the previous six months

• acute muscular-skeletal problem, stroke or cardio-respiratory disease.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Mild Dementia
• Moderate Dementia

Intervention

Behavioral:
• BUDPA Program
The overall program includes 12 weekly 1-hour training class. Each session starts with a 10-minute warm-up period using stretching exercise and stationary mobilizing exercise for trunk and limb joints at both upper and lower bodies (e.g. shoulders, elbows, wrists, hips, knees and ankles), and followed by a session of four to six selected partnering exercise, with duration increase gradually from 20 minutes to 40minutes in four weeks' time. The Borg Rate of Perceived Exertion (Borg RPE) will be used to monitor the exercise intensity. The Research assistant will explain the Borg RPE scale to the subjects and instruct them to speed up or slow down their movements. The training session will end with a 10-minute cool down session with walking exercise and stationary trunk and limb mobilizing exercise involving joints of shoulders, elbows, wrists, hips, knees, and ankles.

Other:
• Control arm (Usual care)
Active Comparator: Usual Care Activities will be provided by the elderly community center such as dementia or caregiver supporting service. They will be allowed to use the regular service provided such services are not related to physical activity or exercise training

Locations

Country	Name	City	State
Hong Kong	School of Nursing, LKS Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (14)

American 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. — View Citation

Chen 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. — View Citation

Chu 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. — View Citation

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. — View Citation

Gellert 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. — View Citation

Hernandez 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. — View Citation

Ko 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. — View Citation

Leung 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. — View Citation

Lou 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. — View Citation

Prick 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. — View Citation

Puterman 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. — View Citation

Van'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. — View Citation

Yeung 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. — View Citation

Yu 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	6th week
Primary	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	12th week
Primary	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	18th week
Primary	Zarit Burden Interview (Chinese version; ZBI-C)	measuring the caregiving burden of the family caregivers	Baseline
Primary	Zarit Burden Interview (Chinese version; ZBI-C)	measuring the caregiving burden of the family caregivers	6th week
Primary	Zarit Burden Interview (Chinese version; ZBI-C)	measuring the caregiving burden of the family caregivers	12th week
Primary	Zarit Burden Interview (Chinese version; ZBI-C)	measuring the caregiving burden of the family caregivers	18th week
Secondary	Neuro-psychiatric Inventory (CNPI; Chinese version)	Evaluating neuro-psychiatric symptoms of the PwD	Baseline
Secondary	Neuro-psychiatric Inventory (CNPI; Chinese version)	Evaluating neuro-psychiatric symptoms of the PwD	6th week
Secondary	Neuro-psychiatric Inventory (CNPI; Chinese version)	Evaluating neuro-psychiatric symptoms of the PwD	12th week
Secondary	Neuro-psychiatric Inventory (CNPI; Chinese version)	Evaluating neuro-psychiatric symptoms of the PwD	18th week
Secondary	Lawton Instrumental activities of daily living IADL(IADL) Questionnaire	Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd	Baseline
Secondary	Lawton Instrumental activities of daily living IADL(IADL) Questionnaire	Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd	6th week
Secondary	Lawton Instrumental activities of daily living IADL(IADL) Questionnaire	Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd	12th week
Secondary	Lawton Instrumental activities of daily living IADL(IADL) Questionnaire	Measuring the ability of engaging in instrumental Activities of daily living(ADL) for the Pwd	18th week
Secondary	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	Baseline
Secondary	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	6th week
Secondary	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	12th week
Secondary	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	18th week
Secondary	Positive Affect Index	Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.	Baseline
Secondary	Positive Affect Index	Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.	6th week
Secondary	Positive Affect Index	Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.	12th week
Secondary	Positive Affect Index	Assessing the current relationship quality of family caregivers with PwD. It covers the feelings of understanding, trust, respect, fairness and affection.	18th week
Secondary	Positive Aspects of Caregiving Scale	To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.	Baseline
Secondary	Positive Aspects of Caregiving Scale	To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.	6th week
Secondary	Positive Aspects of Caregiving Scale	To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.	12th week
Secondary	Positive Aspects of Caregiving Scale	To measure caregiver gain of the family caregivers. It measures two components, self-affirmation and outlook on life.	18th week

External Links

•   Alzheimer's Disease International. World Alzheimer Report-2015
•   Alzheimer's Disease International. World Alzheimer Report-2016
•   Centers for Disease Control and Prevention. Perceived exertion (Borg Rating of Perceived Exertion Scale)
•   World Health Organization. Dementia: A public health priority