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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05531396
Other study ID # 202205012RINC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 5, 2022
Est. completion date June 30, 2023

Study information

Verified date May 2022
Source National Taiwan University Hospital
Contact Yan Ci Liu, PhD
Phone +886233668135
Email yanciliu@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 30, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: 1. older than 65 years old 2. score of Mini-Mental State Examination (MMSE) = 24 3. able to walk independently for more than 30 meters without assistive aids 4. able to follow orders Exclusion Criteria: 1. poorly controlled or unstable systematic disease 2. has a history of central nervous system disease 3. currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain 4. has other medical conditions for which exercise is contraindicated; (5) subjects with achromatopsia.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Agility Training
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Montreal Cognitive Assessment (MoCA) 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
Other Working memory The backward digit span test (DGS) will be used to measure working memory. Baseline, 8 weeks, and 12 weeks
Other Mental set shifting 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
Other Selective attention and inhibition The Stroop Color and Word Test (SCWT) will be used to measure selective attention. Baseline, 8 weeks, and 12 weeks
Other Motor Function 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
Primary Agility Challenge for the Elderly (ACE) 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 Fall history and fear of falls 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
Secondary Quality of life (QOL) 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
Secondary Brain activation 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
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