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

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ClinicalTrials.gov Identifier: NCT03839563
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Taipei Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fallers Mild Cognitive Impairment Behavioral: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Exercise
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
Experimental: 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.
 Behavioral: Exercise
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Gait characteristics [ Time Frame: 12 months ]
    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.

  2. Global cognition [ Time Frame: 12 months ]
    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.

  3. Serum levels of BDNF [ Time Frame: 12 months ]
    Serum BDNF concentrations will be assessed.

  4. Serum levels of IGF-1 [ Time Frame: 12 months ]
    Serum IGF-1 concentrations will be assessed.

  5. Serum levels of VEGF [ Time Frame: 12 months ]
    Serum VEGF concentrations will be assessed.


Secondary Outcome Measures :
  1. Tinetti balance [ Time Frame: 12 months ]
    The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.

  2. Mobility [ Time Frame: 12 months ]
    The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.

  3. Muscle strength [ Time Frame: 12 months ]
    Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.

  4. Falls [ Time Frame: 12 months ]
    number of falls and multiple falls

  5. Depressive symptoms [ Time Frame: 12 months ]
    Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).

  6. Fear of falling [ Time Frame: 12 months ]
    Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839563


Contacts
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Contact: Mau-Roung Lin, Professor 886-2-27361661 ext 6572 mrlin@tmu.edu.tw

Locations
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Taiwan
Taipei Medical University Recruiting
Taipei, Taiwan, 110
Contact: Chih-Yi Chen, Master    886-2-27361661 ext 6572    m513090003@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University
National Health Research Institutes, Taiwan
Investigators
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Principal Investigator: Mau-Roung Lin, Professor Taipei Medical University
More Information
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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03839563    
Other Study ID Numbers: NHRI-EX108-10804PI
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University:
Biomarker
Cognitive impairment
Gait abnormality
Older Adults
Exercise
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders