NCT03621267

Brief Summary

The present study is to examine the effects of interactive stepping exercise on executive function and gait variability in community-dwelling 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
11 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

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

July 29, 2018

Last Update Submit

September 8, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • Executive Interview 25 questions

    Executive Function

    Change from Baseline at 12 weeks

  • Gait Variability

    Stride length and Stride time variability

    Change from Baseline at 12 weeks

Secondary Outcomes (4)

  • Gait velocity

    Change from Baseline at 12 weeks

  • Stride length

    Change from Baseline at 12 weeks

  • Stride time

    Change from Baseline at 12 weeks

  • Functional Ambulation in community

    Change from Baseline at 12 weeks

Study Arms (2)

Interactive Stepping Exercise

EXPERIMENTAL

Interactive Stepping Exercise (1 hour, 3 times/week, 12 weeks) The 1-hour training program will start with10 minutes warm-up session, after that 40 minutes of ISE, and ended with 10 minutes of cool down session. Interactive Stepping Exercise (ISE) will perform on a thin mat that was partitioned into 24 squares. The ISE program included forward, backward, lateral and oblique steps, and step patterns were progressively made more complicated.

Other: Interactive Stepping Exercise

Home exercise program

ACTIVE COMPARATOR

60 minutes, 3 times/week, 12 weeks of home exercise

Other: Home exercise program

Interventions

Interactive Stepping Exercise will perform on a thin mat, stepping pattern will display through a monitor screen, immediate auditory feedback will give for adjustment

Interactive Stepping Exercise

Home exercise program includes stretching exercise, general strengthening exercise on lower extremity muscles, posture control and balance exercise.

Home exercise program

Eligibility Criteria

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

You may qualify if:

  • community-dwelling older adults
  • age ≥ 65 years old
  • able to walk independently outdoor without an assistive device
  • Mini-mental state examination ≥ 24
  • use an exercise pre-participation health screening form by the American College of Sports Medicine to recruit those participants that are suitable to join the training session

You may not qualify if:

  • diagnosed of any psychiatric and neurologic disorders such as schizophrenia, stroke, Parkinson, Alzheimer disease, etc.
  • any comorbidity or disability that would preclude training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, Beitou, 112, Taiwan

RECRUITING

Study Officials

  • Yea-Ru Yang, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

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 29, 2018

First Posted

August 8, 2018

Study Start

September 5, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations