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

NCT03839563 | Unknown DMC

• 1 other identifier: NHRI-EX108-10804PI
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Keywords

Biomarker; Cognitive impairment; Gait abnormality; Older Adults; Exercise

Outcome Measures

Primary Outcomes (5)

• Gait characteristics

  Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.

  12 months

• Global cognition

  Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0\~30, with lower scores indicating poorer global cognition.

  12 months

• Serum levels of BDNF

  Serum BDNF concentrations will be assessed.

  12 months

• Serum levels of IGF-1

  Serum IGF-1 concentrations will be assessed.

  12 months

• Serum levels of VEGF

  Serum VEGF concentrations will be assessed.

  12 months

Secondary Outcomes (6)

• Tinetti balance

  12 months

• Mobility

  12 months

• Muscle strength

  12 months

• Falls

  12 months

• Depressive symptoms

  12 months

Study Arms (3)

Conventional exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Tai chi chuan

EXPERIMENTAL

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.

Behavioral: Exercise

Health education/usual physical activity

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

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

Conventional exercise; Tai chi chuan

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Mobility Limitation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mau-Roung Lin, Professor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mau-Roung Lin, Professor

CONTACT

886-2-27361661; mrlin@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 15, 2019
• Study Start: February 15, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)