Interactive Stepping Exercise on Executive Function and Gait Variability

Effects of Interactive Stepping Exercise on Executive Function and Gait Variability in Community-dwelling Older Adults

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

Study Overview

• Status: Unknown
• Conditions: Health Service for the Aged
• Intervention / Treatment: Other: Interactive Stepping Exercise; Other: Home exercise program

Detailed Description

This is a single blinded, randomized controlled trial. 40 community-dwelling older adults will be recruited and randomly assigned to either experimental group (n=20) or control group (n=20). The 12-week intervention comprises of 1-hour exercise per day and 3 days per week. The experimental group will receive interactive stepping exercise while the control group will be put under home exercise program. Primary outcome measures are executive function and gait variability. Secondary outcome measures include community walking test and other gait parameters (gait velocity, stride length and stride time). The participants will receive assessment at pre- and post-intervention

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou
    • Taipei, Beitou, Taiwan, 112
      • Recruiting
      • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interactive Stepping Exercise; 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; Interactive Stepping Exercise will perform on a thin mat, stepping pattern will display through a monitor screen, immediate auditory feedback will give for adjustment
ACTIVE_COMPARATOR: Home exercise program; 60 minutes, 3 times/week, 12 weeks of home exercise	Other: Home exercise program; Home exercise program includes stretching exercise, general strengthening exercise on lower extremity muscles, posture control and balance exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait velocity	Gait speed	Change from Baseline at 12 weeks
Stride length	The distance covered by the combined step length of each limb during gait	Change from Baseline at 12 weeks
Stride time	The time elapsed between the first contact of two consecutive footsteps of the same foot	Change from Baseline at 12 weeks
Functional Ambulation in community	Walk for 400 m distance in community	Change from Baseline at 12 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2018
• Primary Completion (ANTICIPATED): July 31, 2019
• Study Completion (ANTICIPATED): July 31, 2019

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: YM107053F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No