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

NCT ID: NCT05537363

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Healthy adults

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy elderly and mild cognitive impairment elderly

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mild cognitive impairment elderly with health education

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.

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: OTHER

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

Mild cognitive impairment elderly with multicomponent training

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.

Group Type: EXPERIMENTAL

Multicomponent training

Intervention Type: 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.

Mild cognitive impairment elderly with agility training

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.

Group Type: EXPERIMENTAL

Agility training

Intervention Type: 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 health education

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.

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: 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 multicomponent training

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.

Group Type: EXPERIMENTAL

Multicomponent training

Intervention Type: 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 agility training

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.

Group Type: EXPERIMENTAL

Agility training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Multicomponent training

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.

Intervention Type: OTHER

Agility training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. has a score of ≥ 24 on the Mini-Mental State Examination (MMSE)

2. able to walk independently for more than 30 meters without assistive aids

3. able to follow orders

1. older than 65 years old

2. score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26

3. able to walk independently for more than 30 meters without assistive aids

4. able to follow orders

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. subjects with achromatopsia

Part 2:

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

Part 3:

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Ci Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Central Contacts

Yan Ci Liu, PhD

Role: CONTACT

yanciliu@ntu.edu.tw

+886233668135

Other Identifiers

202112236RINB

Identifier Type: -

Identifier Source: org_study_id