NCT04951258

Brief Summary

People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

June 18, 2021

Last Update Submit

August 21, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Mini-Mental State Examination

    It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.

    Change from baseline at 9 week

  • Chinese version of Verbal learning test

    It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.

    Change from baseline at 9 week

  • Chinese version of Stroop color and word test

    It is a measurement to evaluate inhibition control.

    Change from baseline at 9 week

  • Digit span test

    It is a measurement to evaluate working memory.

    Change from baseline at 9 week

  • Trail making test - Chinese version

    It is a measurement to evaluate cognitive flexibility.

    Change from baseline at 9 week

Secondary Outcomes (7)

  • Barthel index

    Change from baseline at 9 week

  • Instrumental activities of daily living (IADL) scale

    Change from baseline at 9 week

  • Chinese version of Quality of Life in Alzheimer Disease Scale

    Change from baseline at 9 week

  • Time up and go test

    Change from baseline at 9 week

  • 30-second chair stand test

    Change from baseline at 9 week

  • +2 more secondary outcomes

Study Arms (2)

Multicomponent exercise group

EXPERIMENTAL
Other: Multicomponent exercise

Video home exercise group

ACTIVE COMPARATOR
Other: Video home exercise group

Interventions

The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching

Multicomponent exercise group

The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise

Video home exercise group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 60-80 y/o
  • Mini-Mental State Examination: 10-26
  • Clinical Dementia Rating: 1-2
  • Walk at least 6 meters independently (with or without walking aids)

You may not qualify if:

  • Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
  • Physical or psychological comorbidities that affect performance during assessment or intervention
  • Already participating in other physical training in the last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Yea-Ru Yang, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 6, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08