National Taiwan University
Taipei, Taiwan
NCT Number: NCT05537363
The following three-part proposal will focus on the effects of agility training as well as the relationship between agility ability and motor and cognitive function, and risk of falls in elderly adults with or without mild cognitive impairment (MCI).
Part I is a cross-sectional study design that will assess the level of agility in healthy young adults, healthy elderly adults, and elderly adults with MCI to determine the effect of aging and cognition decline on agility and the relations between agility, cognitive, and motor functions. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests, as well as an agility test. Cognitive function tests include tests of global cognition, working memory, mental set shifting, and selective attention. Motor function tests include tests of single and dual task walking, strength, power, balance, flexibility, and endurance. The agility test contains stop-and-go, change of direction, and spatial orientation components. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the agility test, cognitive tests, and single and dual task walking. Results from all tests will be used to determine the motor, cognitive, and other predictive factors associated with agility performance, and will be used in the design of the training program in Part II and III.
Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a multicomponent training and an agility training protocol on agility, motor, and cognitive function in elderly adults with and without MCI. Seventy-five elderly adults with MCI (Part II) and seventy-five healthy elderly (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor, cognitive, and agility tests used in Part I, information on history of falls, falls efficacy, and quality of life will be assessed for each participant. Brain activation will be assessed during the agility test, cognitive tests, and single and dual task walking assessments using fNIRS. Participants will be randomly allocated into one of three groups: the control group, the multicomponent training group, or the agility training group (n=25 in each group). Intervention will be executed at a frequency of 45 minutes per session, 2 times a week for 8 weeks. The control group will receive home-based health education guidelines. The multicomponent training group will engage in 3 to 4 exercises each training session comprising the influencing factors of agility, and the agility training group will engage in integrated task-specific training. A post-test will be conducted after the 8-week intervention, and 1-month, 6-month, and 12-month follow-ups will be conducted for elderly adults with MCI. The healthy elderly adults will be assessed after the intervention and at the 1-month follow-up after training.
Looking for future studies?
Notify Me20 year–100 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Part 1:
Inclusion criteria
Exclusion criteria
Part 2:
Inclusion criteria
Exclusion criteria
Part 3:
Inclusion criteria
Exclusion criteria
Participants in the control group will receive health educational guidelines. Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education.
Multicomponent exercises will be designed according to the results of Part I of our study. Results of Part I of this study will determine the contributing factors of agility, such as muscle strength, endurance, and cognitive function. A physical therapist will train the participants 3-4 exercises (3-4 factors) in each session. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
The agility-based task-specific exercises will be conducted in this group and will incorporate stop-and-go, change in direction, change in velocity, acceleration and deceleration training. There are four training configurations with 3 levels of difficulty, which will be manipulated by increasing speed, distance, number of repetitions, number of directions, congruency, and/or complexity of the task, or by decreasing the number and duration of the rest intervals. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Fall history will be recorded by the number of fall episodes in the past 6 months and whether it caused injury.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
The backward digit span test (DGS) will be used to measure working memory.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
The Stroop Color and Word Test (SCWT) will be used to measure selective attention.
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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).
National Taiwan University Hospital
Other
The Effects of an Agility Training and Its Relation to Motor, Cognitive Performance and Fall Risk in Elderly Adults With and Without Mild Cognitive Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07747675
Cognition Disorders, Cognitive Dysfunction
View Trial DetailsNCT07282626
Behavior, Community Dwelling
Kaohsiung City, Taiwan
View Trial DetailsNCT01732653
Basal Ganglia Diseases, Brain Diseases
Leuven, Belgium
View Trial DetailsNCT02703220
Apnea, Dyssomnias
Detroit, Michigan, United States
View Trial Details