NCT05558839

Brief Summary

This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community-dwelling older adults with dementia. The exercise and cognitive training intervention of this study promoted physical fitness, reduced chance of falling, and improved the cognitive functions of community-dwelling older adults with dementia. In addition, the score of risk of falling reduced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 7, 2022

Last Update Submit

September 25, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • functional physical fitness

    Physiological measurements: * The 30 second chair stand test is for testing leg strength and endurance in older adults. This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded. This reflects lower body strength. * The handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. * The 8-foot up-and-go test is used to measure balance, agility, and speed while walking or moving.

    14 weeks (Before and after interventions)

  • Falls risk assessment

    We reported fall risk was assessed with the STRATIFY assessment tool(St. Thomas Risk Assessment Tool in Falling Elderly Inpatients) by questionnaire. Falls risk assessment tool is used to identify fall risk factors for falls in the elderly and to predict the chance of falling. This tool comprises five items addressing risk factors: past history of falling, patient agitation, visual impairment, incontinence, transfer and mobility. The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling is a score ≥ 2 points.

    14 weeks (Before and after interventions)

  • Cognitive Assessment

    We reported cognitive assessment was assessed with the Taiwan version of Montreal Cognitive Assessment (MoCA-T) by questionnaire. The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and takes around 10 to 12 minutes to complete. The MoCA checks different types of cognitive or thinking abilities. These include: orientation, short-term memory/delayed recall, executive function/visuospatial ability, language, abstraction, animal naming, attention, and clock-drawing test. The MoCA test uses a 30-point scale and take only 10 to 12 minutes. to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.

    14 weeks (Before and after interventions)

Study Arms (2)

exercise training

EXPERIMENTAL

Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.

Behavioral: A 12-week weekly sports and cognitive training intervention.

cognitive training

EXPERIMENTAL

Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm. Each cognitive session uses different board games to strengthen training for different cognitive aspects.

Behavioral: A 12-week weekly sports and cognitive training intervention.

Interventions

A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved 1 hour of sports training and 1 hour of cognitive training.

cognitive trainingexercise training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The list of dementia cases under the supervision of the Taipei City Government Health Bureau, who are over 65 years of age and have been diagnosed with mild to moderate dementia.
  • Those who can participate in sports activities.
  • Those who can communicate in both Chinese and Taiwanese, have self-determination ability and can clearly express their wishes.

You may not qualify if:

  • Those who have exercise contraindications due to medical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

DementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Chang Hui-Wen, M.D.

    member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community-dwelling older adults with mild or moderate dementia.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 28, 2022

Study Start

April 6, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations