Agility Training and Its Relations in Elderly Adults With and Without MCI

NCT05537363 | Unknown

• 1 other identifier: 202112236RINB
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Elderly Adults; Mild Cognitive Impairment; Healthy

Keywords

Aging; Agility training; Cognition function; Fall; Mild Cognitive Impairment; Motor function

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.

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

Secondary Outcomes (8)

• Fall history and fear of falls

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

• Quality of life (QOL)

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

• Brain activation

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

• Montreal Cognitive Assessment (MoCA)

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

• Mental set shifting

  Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

Study Arms (8)

Healthy adults

NO INTERVENTION

Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.

Healthy elderly and mild cognitive impairment elderly

NO INTERVENTION

Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.

Mild cognitive impairment elderly with health education

ACTIVE COMPARATOR

Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

Other: Health education

Mild cognitive impairment elderly with multicomponent training

EXPERIMENTAL

Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

Other: Multicomponent training

Mild cognitive impairment elderly with agility training

EXPERIMENTAL

Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

Other: Agility training

Healthy elderly with health education

ACTIVE COMPARATOR

Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

Other: Health education

Healthy elderly with multicomponent training

EXPERIMENTAL

Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

Other: Multicomponent training

Healthy elderly with agility training

EXPERIMENTAL

Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

Other: Agility training

Interventions

Health education OTHER

Participants in the control group will receive health educational guidelines. Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education.

Healthy elderly with health education; Mild cognitive impairment elderly with health education

Multicomponent training OTHER

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.

Healthy elderly with multicomponent training; Mild cognitive impairment elderly with multicomponent training

Agility training OTHER

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.

Healthy elderly with agility training; Mild cognitive impairment elderly with agility training

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has a score of ≥ 24 on the Mini-Mental State Examination (MMSE)
• 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
• subjects with achromatopsia
• Part 2:
• older than 65 years old
• score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26
• able to walk independently for more than 30 meters without assistive aids
• able to follow orders
• 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
• subjects with achromatopsia
• Part 3:

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yan Ci Liu, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Ci Liu, PhD

CONTACT

+886233668135; yanciliu@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: July 24, 2022
• First Posted: September 13, 2022
• Study Start: September 10, 2022
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 13, 2022

Record last verified: 2022-05