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

Primary Purpose

Fallers, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fallers focused on measuring Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Taipei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Conventional exercise

Tai chi chuan

Health education/usual physical activity

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Serum levels of BDNF
Serum BDNF concentrations will be assessed.
Serum levels of IGF-1
Serum IGF-1 concentrations will be assessed.
Serum levels of VEGF
Serum VEGF concentrations will be assessed.

Secondary Outcome Measures

Tinetti balance
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
Mobility
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.
Muscle strength
Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.
Falls
number of falls and multiple falls
Depressive symptoms
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.

Full Information

First Posted
January 31, 2019
Last Updated
September 28, 2022
Sponsor
Taipei Medical University
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03839563
Brief Title
Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
Official Title
Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallers, Mild Cognitive Impairment
Keywords
Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Tai chi chuan
Arm Type
Experimental
Arm Description
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.
Arm Title
Health education/usual physical activity
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
Primary Outcome Measure Information:
Title
Gait characteristics
Description
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.
Time Frame
12 months
Title
Global cognition
Description
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.
Time Frame
12 months
Title
Serum levels of BDNF
Description
Serum BDNF concentrations will be assessed.
Time Frame
12 months
Title
Serum levels of IGF-1
Description
Serum IGF-1 concentrations will be assessed.
Time Frame
12 months
Title
Serum levels of VEGF
Description
Serum VEGF concentrations will be assessed.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Tinetti balance
Description
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
Time Frame
12 months
Title
Mobility
Description
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.
Time Frame
12 months
Title
Muscle strength
Description
Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.
Time Frame
12 months
Title
Falls
Description
number of falls and multiple falls
Time Frame
12 months
Title
Depressive symptoms
Description
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).
Time Frame
12 months
Title
Fear of falling
Description
Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mau-Roung Lin, Professor
Phone
886-2-27361661
Ext
6572
Email
mrlin@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mau-Roung Lin, Professor
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Yi Chen, Master
Phone
886-2-27361661
Ext
6572
Email
m513090003@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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