NCT03611192

Brief Summary

The present study is to examine the effects of a multicomponent exercise on executive function and balance in pre-frail older adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

July 25, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

July 25, 2018

Last Update Submit

August 6, 2018

Conditions

Health Services for the Aged

Keywords

Multicomponent ExerciseExecutive FunctionBalancePre-frail

Outcome Measures

Primary Outcomes (6)

  • Trail-Making test

    Executive function

    Change from baseline at 12 weeks

  • Stroop test

    Executive function

    Change from baseline at 12 weeks

  • Digit span test

    Executive function

    Change from baseline at 12 weeks

  • Mini-Balance Evaluation Systems Test

    Balance

    Change from baseline at 12 weeks

  • Time Up & Go test

    Balance

    Change from baseline at 12 weeks

  • One leg standing test

    Balance

    Change from baseline at 12 weeks

Secondary Outcomes (2)

  • Montreal Cognitive Assessment

    Change from Baseline at 12 weeks

  • Fried frailty criteria

    Change from baseline at 12 weeks

Study Arms (2)

Multicomponent exercise group

EXPERIMENTAL
Other: Multicomponent exercise

Home-program exercise group

ACTIVE COMPARATOR
Other: Home-program exercise

Interventions

Multicomponent exerciseOTHER

Aerobic exercise: 15\~20 mins Resistance exercise: 15 mins Balance exercise: 15\~20 mins Flexibility exercise: 10 mins

Multicomponent exercise group
Home-program exerciseOTHER

60 mins exercise

Home-program exercise group

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age≥ 65
  • Pre-frail according to the Fried Physical Frailty Phenotype
  • Community-dwelling and able to walk independently\>6m

You may not qualify if:

  • Unstable medical condition (ACSM Health Facility Pre-participation Screening Questionnaire)
  • Neurological conditions(eg, Parkinson's disease, stroke, multiple sclerosis)
  • MMSE\<24
  • Visual or color discrimination impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

RECRUITING

Study Design

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

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 2, 2018

Study Start

August 6, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

TW(1)