- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611192
Multicomponent Exercise on Executive Function and Balance
August 6, 2018 updated by: Yea-Ru Yang, National Yang Ming University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 112
- Recruiting
- National Yang-Ming University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Age≥ 65
- Pre-frail according to the Fried Physical Frailty Phenotype
- Community-dwelling and able to walk independently>6m
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multicomponent exercise group
|
Aerobic exercise: 15~20 mins Resistance exercise: 15 mins Balance exercise: 15~20 mins Flexibility exercise: 10 mins
|
|
Active Comparator: Home-program exercise group
|
60 mins exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trail-Making test
Time Frame: Change from baseline at 12 weeks
|
Executive function
|
Change from baseline at 12 weeks
|
|
Stroop test
Time Frame: Change from baseline at 12 weeks
|
Executive function
|
Change from baseline at 12 weeks
|
|
Digit span test
Time Frame: Change from baseline at 12 weeks
|
Executive function
|
Change from baseline at 12 weeks
|
|
Mini-Balance Evaluation Systems Test
Time Frame: Change from baseline at 12 weeks
|
Balance
|
Change from baseline at 12 weeks
|
|
Time Up & Go test
Time Frame: Change from baseline at 12 weeks
|
Balance
|
Change from baseline at 12 weeks
|
|
One leg standing test
Time Frame: Change from baseline at 12 weeks
|
Balance
|
Change from baseline at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment
Time Frame: Change from Baseline at 12 weeks
|
Global cognition
|
Change from Baseline at 12 weeks
|
|
Fried frailty criteria
Time Frame: Change from baseline at 12 weeks
|
Frailty reverse
|
Change from baseline at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2018
Primary Completion (Anticipated)
July 31, 2019
Study Completion (Anticipated)
July 31, 2019
Study Registration Dates
First Submitted
July 25, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
August 8, 2018
Last Update Submitted That Met QC Criteria
August 6, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- YM107051F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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