- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531396
Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly
September 5, 2022 updated by: National Taiwan University Hospital
The Effects of Agility Training and Its Relations on Physical Performance, Cognitive Function and Brain Activities in Elderly
Agility comprised of cognitive and physical functions, which influences whole-body movement with change of speed and direction.
Agility training is widely used in athletes, and recent studies have begun to apply it into the elderly.
Agility training is multidimensional and highly functional, which makes it possible to provide more efficient training in limited time.
In elderly, the decrement of cognitive function, muscle strength in the upper and lower limbs, the percentage of body fat, body flexibility and endurance caused by aging will make it difficult for the elderly to perform movements.
Therefore, it is essential to explore whether agility training can achieve the improvement of the physical function and cognitive function in elderly, and to find the relationship between the two functions and brain activity.
Method: This study will recruit 60 participants, and randomly allocate to control group and agility training.
The training groups will have 8 weeks of training, 2 times a week, 45 minutes of training each time.
Assessment will be performed before and after intervention in 1-week, and with 1-month follow-up.
Assessment including agility ability, physical function, cognitive function, brain activity, and functional assessment scales.
Study Overview
Status
Not yet recruiting
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 Contact
- Name: Yan Ci Liu, PhD
- Phone Number: +886233668135
- Email: yanciliu@ntu.edu.tw
Study Contact Backup
- Name: Yi Ting Hung, BS
- Phone Number: +886233668135
- Email: r09428008@ntu.edu.tw
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:
- older than 65 years old
- score of Mini-Mental State Examination (MMSE) ≥ 24
- able to walk independently for more than 30 meters without assistive aids
- able to follow orders
Exclusion Criteria:
- poorly controlled or unstable systematic disease
- has a history of central nervous system disease
- currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
- has other medical conditions for which exercise is contraindicated; (5) subjects with achromatopsia.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Health Education
|
Participants in the control group will receive health educational guidelines.
Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education.
The home-based exercise program will emphasize how to safely and properly perform stretching and whole-body exercises.
|
Experimental: Agility Training Group
|
Participants will receive 60 minutes of exercise, twice a week, for a total of 8 weeks, and training will be conducted by a well-trained physical therapist.
The intervention will comprise a 5-minute warm-up, 45 minutes of main exercise, and a 10-minute cool-down period, for a total of 60 minutes each session.
During the warm-up and cool-down, participants will do static and dynamic whole-body stretching exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agility Challenge for the Elderly (ACE)
Time Frame: Baseline, 8 weeks, and 12 weeks
|
An agility course developed for a 9m x 18m volleyball court and includes three segments that each aim to test a specific aspect of agility, including stop-and-go, change of direction, and spatial orientation.
|
Baseline, 8 weeks, and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall history and fear of falls
Time Frame: Baseline, 8 weeks, and 12 weeks
|
Fall history will be recorded by the number of fall episodes in the past 6 months and whether it caused injury.
|
Baseline, 8 weeks, and 12 weeks
|
Quality of life (QOL)
Time Frame: Baseline, 8 weeks, and 12 weeks
|
Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
|
Baseline, 8 weeks, and 12 weeks
|
Brain activation
Time Frame: Baseline, 8 weeks, and 12 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the hemodynamics of brain areas associated with the agility test, cognitive tasks, and single and dual task walking test.
|
Baseline, 8 weeks, and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, 8 weeks, and 12 weeks
|
MoCA contains 16 items and 11 categories to assess multiple cognitive domains, is a screening instrument for MCI, and its validity has been established in various clinical groups and countries.
|
Baseline, 8 weeks, and 12 weeks
|
Working memory
Time Frame: Baseline, 8 weeks, and 12 weeks
|
The backward digit span test (DGS) will be used to measure working memory.
|
Baseline, 8 weeks, and 12 weeks
|
Mental set shifting
Time Frame: Baseline, 8 weeks, and 12 weeks
|
The Wisconsin Card Sorting Test (WCST) will be used to measure participants' ability to shift their cognitive ability in response to the demands of environment.
|
Baseline, 8 weeks, and 12 weeks
|
Selective attention and inhibition
Time Frame: Baseline, 8 weeks, and 12 weeks
|
The Stroop Color and Word Test (SCWT) will be used to measure selective attention.
|
Baseline, 8 weeks, and 12 weeks
|
Motor Function
Time Frame: Baseline, 8 weeks, and 12 weeks
|
Walking performance, normal walking, cognitive dual-task walking, muscle strength of bilateral lower limbs, five times sit to stand test, timed up and go, quiet static standing task, and the 360° turning task, flexibility, 6-minute walk test (6WMT)
|
Baseline, 8 weeks, and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yan Ci Liu, PhD, National Taiwan University
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 (Anticipated)
September 5, 2022
Primary Completion (Anticipated)
May 23, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
August 5, 2022
First Submitted That Met QC Criteria
September 5, 2022
First Posted (Actual)
September 8, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202205012RINC
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Health Education
-
Federal University of PelotasRecruiting
-
University of PretoriaUnknown
-
Universiti Sains MalaysiaNot yet recruitingKnowledge, Attitudes, Practice | Early Childhood Caries
-
Junyan ZhaoActive, not recruitingTumor Chemotherapy PatientsChina
-
Tianjin HospitalCompletedLumbar Disc HerniationChina
-
Federal University of PelotasRecruitingBreast Cancer FemaleBrazil
-
Taipei Medical UniversityActive, not recruiting
-
Chang Gung University of Science and TechnologyEnrolling by invitation
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedEarly Detection of CancerTurkey
-
University of WashingtonNational Institute on Aging (NIA)RecruitingOsteo Arthritis KneeUnited States