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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05537363
• Other study ID #: 202112236RINB
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: December 31, 2025

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
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Part 1:

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

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:

Inclusion Criteria:

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

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

Part 3:

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Elderly Adults
• Healthy
• Mild Cognitive Impairment

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	Quality of life (QOL)	Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
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.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	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.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	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.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	Working memory	The backward digit span test (DGS) will be used to measure working memory.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	Selective attention and inhibition	The Stroop Color and Word Test (SCWT) will be used to measure selective attention.	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary	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).	Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month