Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

NCT ID: NCT03839563

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2023-12-31

Brief Summary

The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.

Conditions

Fallers; Mild Cognitive Impairment

Study Design

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

Study Groups

Conventional exercise

This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.

Tai chi chuan

The 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.

Health education/usual physical activity

After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least 65 years old
• Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
• Can ambulate independently
• Has mild cognitive impairment

Exclusion Criteria

• Do not live in a community setting
• Cannot ambulate independently and communicate with researchers
• Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
• Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mau-Roung Lin, Professor

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Mau-Roung Lin, Professor

Role: CONTACT

mrlin@tmu.edu.tw

886-2-27361661 ext. 6572

Facility Contacts

Chih-Yi Chen, Master

Role: primary

m513090003@tmu.edu.tw

886-2-27361661 ext. 6572

Other Identifiers

NHRI-EX108-10804PI

Identifier Type: -

Identifier Source: org_study_id