NCT05531396

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 8, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

August 5, 2022

Last Update Submit

September 5, 2022

Conditions

ElderlyHealthy

Keywords

Agility trainingPhysical functionCognition functionElderlyFunctional near-infrared spectroscopy (fNIRS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Fall history and fear of falls

    Baseline, 8 weeks, and 12 weeks

  • Quality of life (QOL)

    Baseline, 8 weeks, and 12 weeks

  • Brain activation

    Baseline, 8 weeks, and 12 weeks

Other Outcomes (5)

  • Montreal Cognitive Assessment (MoCA)

    Baseline, 8 weeks, and 12 weeks

  • Working memory

    Baseline, 8 weeks, and 12 weeks

  • Mental set shifting

    Baseline, 8 weeks, and 12 weeks

  • +2 more other outcomes

Study Arms (2)

Health Education

ACTIVE COMPARATOR
Other: Health Education

Agility Training Group

EXPERIMENTAL
Other: Agility Training

Interventions

Agility TrainingOTHER

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.

Agility Training Group
Health EducationOTHER

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.

Health Education

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yan Ci Liu, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Ci Liu, PhD

CONTACT

+886233668135yanciliu@ntu.edu.tw

Yi Ting Hung, BS

CONTACT

+886233668135r09428008@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

September 8, 2022

Study Start

September 5, 2022

Primary Completion

May 23, 2023

Study Completion

June 30, 2023

Last Updated

September 8, 2022

Record last verified: 2022-05