Health Services for the AgedNCT03611192
Multicomponent Exercise on Executive Function and Balance
A study testing Multicomponent exercise and Home-program exercise in people with Health Services 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 a multicomponent exercise on executive function and balance in pre-frail older adults. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Health Services for the Aged
- What is being tested?
- Multicomponent exercise and Home-program exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Aug 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
- Age≥ 65
- Pre-frail according to the Fried Physical Frailty Phenotype
- Community-dwelling and able to walk independently>6m
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-28267279, yryang@ym.edu.tw
About this study
Official title: Effects of A Multicomponent Exercise on Executive Function and Balance in Pre-frail Older Adults
The present study is to examine the effects of a multicomponent exercise on executive function and balance in pre-frail older adults.
- Conditions
- Health Services for the Aged
- Being tested
- Multicomponent exercise, Home-program exercise
- Keywords
- Multicomponent Exercise, Executive Function, Balance, Pre-frail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseOther
Aerobic exercise: 15~20 mins Resistance exercise: 15 mins Balance exercise: 15~20 mins Flexibility exercise: 10 mins
Home-program exerciseOther
60 mins exercise
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise group | Experimental | Not described Receives: Other: Multicomponent exercise |
| Home-program exercise group | Active comparator | Not described Receives: Other: Home-program exercise |
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
Mini-Balance Evaluation Systems Test
Balance
Measured: Change from baseline at 12 weeks
Time Up & Go test
Balance
Measured: Change from baseline at 12 weeks
One leg standing test
Balance
Measured: Change from baseline at 12 weeks
Secondary outcomes (2)
Montreal Cognitive Assessment
Global cognition
Measured: Change from Baseline at 12 weeks
Fried frailty criteria
Frailty reverse
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 posted2 Aug 2018
- Study start6 Aug 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 Services 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
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611192
- Sponsor's protocol ID
- YM107051F
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 8 Aug 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 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A Multicomponent Exercise on Executive Function and Balance in Pre-frail Older Adults
- ClinicalTrials.gov ID
- NCT03611192
- Acronym / sponsor ID
- YM107051F
- Conditions
- Health Services for the Aged
- Keywords
- Multicomponent Exercise, Executive Function, Balance, Pre-frail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 2 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 a multicomponent exercise on executive function and balance in pre-frail older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise group | Experimental | Other: Multicomponent exercise |
| Home-program exercise group | Active comparator | Other: Home-program exercise |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age≥ 65
- Pre-frail according to the Fried Physical Frailty Phenotype
- Community-dwelling and able to walk independently>6m
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Multicomponent exerciseAerobic exercise: 15~20 mins Resistance exercise: 15 mins Balance exercise: 15~20 mins Flexibility exercise: 10 mins | Other | Multicomponent exercise group |
| Home-program exercise60 mins exercise | Other | Home-program exercise group |
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
Mini-Balance Evaluation Systems Test
Time frame: Change from baseline at 12 weeks
Balance
Time Up & Go test
Time frame: Change from baseline at 12 weeks
Balance
One leg standing test
Time frame: Change from baseline at 12 weeks
Balance
2 secondary outcomes
Montreal Cognitive Assessment
Time frame: Change from Baseline at 12 weeks
Fried frailty criteria
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 8 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise and Home-program exercise in people with Health Services 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 3 inclusion and 4 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 8 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 6 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 8 Aug 2018.