NCT04913818

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

April 16, 2021

Last Update Submit

November 27, 2023

Conditions

Mild DementiaModerate Dementia

Keywords

mild to early moderate dementia

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • Zarit Burden Interview (Chinese version; ZBI-C)

    measuring the caregiving burden of the family caregivers

    Baseline

  • Zarit Burden Interview (Chinese version; ZBI-C)

    measuring the caregiving burden of the family caregivers

    6th week

  • Zarit Burden Interview (Chinese version; ZBI-C)

    measuring the caregiving burden of the family caregivers

    12th week

  • Zarit Burden Interview (Chinese version; ZBI-C)

    measuring the caregiving burden of the family caregivers

    18th week

Secondary Outcomes (20)

  • Neuro-psychiatric Inventory (CNPI; Chinese version)

    Baseline

  • Neuro-psychiatric Inventory (CNPI; Chinese version)

    6th week

  • Neuro-psychiatric Inventory (CNPI; Chinese version)

    12th week

  • Neuro-psychiatric Inventory (CNPI; Chinese version)

    18th week

  • Lawton Instrumental activities of daily living IADL(IADL) Questionnaire

    Baseline

  • +15 more secondary outcomes

Study Arms (2)

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.

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.

Other: Control arm (Usual care)

Interventions

BUDPA ProgramBEHAVIORAL

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.

BUDPA Program
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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 problem, stroke or cardio-respiratory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, LKS Faculty of Medicine

Hong Kong, Hong Kong

Location

Related Publications (14)

  • 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: 25161263BACKGROUND

  • 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.

    PMID: 23883489BACKGROUND

  • 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.

    PMID: 29128685BACKGROUND

  • 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.

    PMID: 25414947BACKGROUND

  • 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.

    PMID: 30266522BACKGROUND

  • 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.

    PMID: 27099480BACKGROUND

  • 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.

    PMID: 28798651BACKGROUND

  • 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.

    PMID: 25125421BACKGROUND

  • 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.

    PMID: 19516148BACKGROUND

  • 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.

    PMID: 11056778BACKGROUND

  • 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.

    PMID: 11536346BACKGROUND

  • 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.

    PMID: 18515696BACKGROUND

  • 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.

    PMID: 12100873BACKGROUND

  • 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.

    PMID: 25488014BACKGROUND

Related Links

Study Officials

  • Doris, Sau Fung YU, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: To examine the feasibility and preliminary effect of a partnering exercise program on the health outcomes of the PwD and their family caregivers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

June 4, 2021

Study Start

June 5, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Only study investigators and research assistants involved in the study will have access to the data.

Locations

HK(1)