Health Service for the AgedNCT03621267
Interactive Stepping Exercise on Executive Function and Gait Variability
A study testing Interactive Stepping Exercise and Home exercise program in people with Health Service for the Aged, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The present study is to examine the effects of interactive stepping exercise on executive function and gait variability in community-dwelling older adults Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Health Service for the Aged
- What is being tested?
- Interactive Stepping Exercise and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- diagnosed of any psychiatric and neurologic disorders such as schizophrenia, stroke, Parkinson, Alzheimer disease, etc.
- any comorbidity or disability that would preclude training
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, Beitou, 112
Yea-Ru Yang, PhD, +886-2-28267279, yryang@ym.edu.tw
About this study
Official title: 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
Read the 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
- Conditions
- Health Service for the Aged
- Being tested
- Interactive Stepping Exercise, Home exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Stepping ExerciseOther
Interactive Stepping Exercise will perform on a thin mat, stepping pattern will display through a monitor screen, immediate auditory feedback will give for adjustment
Home exercise programOther
Home exercise program includes stretching exercise, general strengthening exercise on lower extremity muscles, posture control and balance exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interactive Stepping Exercise |
| Home exercise program | Active comparator | 60 minutes, 3 times/week, 12 weeks of home exercise Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test
Executive Function
Measured: Change from Baseline at 12 weeks
Stroop Test
Executive Function
Measured: Change from Baseline at 12 weeks
Digit Span Test
Executive Function
Measured: Change from Baseline at 12 weeks
Executive Interview 25 questions
Executive Function
Measured: Change from Baseline at 12 weeks
Gait Variability
Stride length and Stride time variability
Measured: Change from Baseline at 12 weeks
Secondary outcomes (4)
Gait velocity
Gait speed
Measured: Change from Baseline at 12 weeks
Stride length
The distance covered by the combined step length of each limb during gait
Measured: Change from Baseline at 12 weeks
Stride time
The time elapsed between the first contact of two consecutive footsteps of the same foot
Measured: Change from Baseline at 12 weeks
Functional Ambulation in community
Walk for 400 m distance in community
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start5 Sep 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Service for the AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
- Investigators
- Yea-Ru Yang, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621267
- Sponsor's protocol ID
- YM107053F
- Status last verified
- Sep 2018
- First submitted
- 29 Jul 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Stepping Exercise on Executive Function and Gait Variability in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03621267
- Acronym / sponsor ID
- YM107053F
- Conditions
- Health Service for the Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is to examine the effects of interactive stepping exercise on executive function and gait variability in community-dwelling older adults
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Stepping Exercise | Experimental | Other: Interactive Stepping ExerciseInteractive 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. |
| Home exercise program | Active comparator | Other: Home exercise program60 minutes, 3 times/week, 12 weeks of home exercise |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- diagnosed of any psychiatric and neurologic disorders such as schizophrenia, stroke, Parkinson, Alzheimer disease, etc.
- any comorbidity or disability that would preclude training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Stepping ExerciseInteractive Stepping Exercise will perform on a thin mat, stepping pattern will display through a monitor screen, immediate auditory feedback will give for adjustment | Other | Interactive Stepping Exercise |
| Home exercise programHome exercise program includes stretching exercise, general strengthening exercise on lower extremity muscles, posture control and balance exercise. | Other | Home exercise program |
Primary outcome
Trail Making Test
Time frame: Change from Baseline at 12 weeks
Executive Function
Stroop Test
Time frame: Change from Baseline at 12 weeks
Executive Function
Digit Span Test
Time frame: Change from Baseline at 12 weeks
Executive Function
Executive Interview 25 questions
Time frame: Change from Baseline at 12 weeks
Executive Function
Gait Variability
Time frame: Change from Baseline at 12 weeks
Stride length and Stride time variability
4 secondary outcomes
Gait velocity
Time frame: Change from Baseline at 12 weeks
Stride length
Time frame: Change from Baseline at 12 weeks
Stride time
Time frame: Change from Baseline at 12 weeks
Functional Ambulation in community
Time frame: Change from Baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yea-Ru Yang, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Stepping Exercise and Home exercise program in people with Health Service for the Aged, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, PhD (+886-2-28267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Test (time frame: Change from Baseline at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.