Older AdultsNCT02102308
Exercise Improves Executive Function and Dual-task Decrements
A study testing Exercise and Education classes in people with Older Adults, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
A 12-week multicomponent exercise is effective in improving executive function and gait performance in dual-task conditions. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Exercise and Education classes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Dec 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age more than 65 years old
- ability to walk outdoor independently without assistive devices
Who cannot join
- unstable medical conditions interfering with participation in the study
- diagnosis of dementia, psychosis, neurological disease, and depression
- unable to receive external information for finishing the neuropsychological tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicomponent Exercise Improves Executive Function and Dual-task Decrements in Gait Among Older Adults
A 12-week multicomponent exercise is effective in improving executive function and gait performance in dual-task conditions.
- Conditions
- Older Adults
- Being tested
- Exercise, Education classes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Multicomponent exercise
Education classesOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Multicomponent exercise Receives: Other: Exercise |
| Education classes | Placebo comparator | Education classes Receives: Other: Education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
spatial and temporal gait parameters
velocity (cm/s), stride time (ms), stride length (cm), stride time variability (%) and stride length variability (%) under single- or two dual-task conditions
Measured: 12 weeks
Secondary outcomes (1)
Executive Interview
This test consisted of 25-item rating for executive function on tasks. Scores ranged from 0 to 2 for each item, and higher scores indicated worse performance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
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
- NCT02102308
- Sponsor's protocol ID
- elderly1
- Other IDs
- NSC100-2314-B-010-021-MY2
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Exercise Improves Executive Function and Dual-task Decrements in Gait Among Older Adults
- ClinicalTrials.gov ID
- NCT02102308
- Acronym / sponsor ID
- elderly1
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Apr 2014 (estimated)
- 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.
A 12-week multicomponent exercise is effective in improving executive function and gait performance in dual-task conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseMulticomponent exercise |
| Education classes | Placebo comparator | Other: Education classesEducation classes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age more than 65 years old
- ability to walk outdoor independently without assistive devices
Key exclusion criteria (3 listed)
- unstable medical conditions interfering with participation in the study
- diagnosis of dementia, psychosis, neurological disease, and depression
- unable to receive external information for finishing the neuropsychological tests
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 |
|---|---|---|
| ExerciseMulticomponent exercise | Other | Exercise |
| Education classes | Other | Education classes |
Primary outcome
spatial and temporal gait parameters
Time frame: 12 weeks
velocity (cm/s), stride time (ms), stride length (cm), stride time variability (%) and stride length variability (%) under single- or two dual-task conditions
1 secondary outcome
Executive Interview
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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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 Exercise and Education classes in people with Older Adults, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Apr 2014. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spatial and temporal gait parameters (time frame: 12 weeks). 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 2 Apr 2014.