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Effects of Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With MCI (MCI-TaiChi)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tai Chi exercise
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, Tai Chi, cognitive functions

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis for MCI based on Petersen's criteria as follows:

    • A self-reported memory complaint, corroborated by an informant interview
    • A score on a standardized memory test rated as 0.5 on Clinical Dementia Rating (CDR)
    • Normal general cognitive function, as determined by a clinician's judgment based on a structured interview with the patient and an informant report and adjusted Thai Mini-Mental State Examination (TMSE) 35
    • No or minimal impairment in activities of daily living (ADLs) or instrumental Activity of Daily Living (IADL), as determined by clinical review with the patients and informant interview
    • Not sufficiently impaired, cognitively and functionally, to meet National Institute of Neurological and Communicative Disorders and Stroke/ Alzheimer's disease and Related Association (NINCDS-ADRDA) criteria for AD, as judged by an experienced AD clinician
  2. Presence of cognitive impairment determined by the score on the Montreal Cognitive Assessment (MoCA) lesser than 26
  3. Comprehend instructions and willing to participate

Exclusion Criteria:

  1. Presence of medical conditions that would be unsafe to exercise
  2. Presence of neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis)
  3. Presence of depressive symptoms, defined by the Geriatric Depression Scale (GDS)-Thai version 36
  4. Presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
  5. Taking alcohol 6 hr before testing or using drug regimens that affect performance such as sedative and antidepressant.
  6. Exercise regularly (40-50 min/day at least 3 days/week)

Sites / Locations

  • Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Tai Chi exercise group

Arm Description

Since no medication or other treatments are currently approved by Food and Drug Administration (FDA) for treatment of MCI, participants in the usual care group will not receive any form of treatment. They will receive an educational material about cognitive impairment. They will also be asked to maintain their daily routine.

The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down.

Outcomes

Primary Outcome Measures

Change from baseline in cognitive functions at 6 months
memory, attention, executive function will be evaluated

Secondary Outcome Measures

Change from baseline in serum biomarkers at 6 months
inflammatory markers will be evaluated.
Change from baseline in fall risk at 6 months
Fall risk index will be evaluated using physiological profile approach (PPA)
Change from baseline in quality of life at 6 months
Health related quality of life will be evaluated using the Short Form 36 (SF-36) questionnaire.
Change from baseline in cognitive functions at 3 months
memory, attention, executive function will be evaluated
Change from baseline in fall risk at 3 months
Fall risk index will be evaluated using physiological profile approach (PPA)

Full Information

First Posted
January 16, 2014
Last Updated
July 27, 2016
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT02552329
Brief Title
Effects of Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With MCI
Acronym
MCI-TaiChi
Official Title
A Randomized Controlled Trial of Mind-body Exercise: Effects of a 6-month Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With Mild Cognitive Impairment (MCI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of MCI. Therefore, the aims of the present study are: 1) to examine the effects of Tai Chi exercise on cognitive function of elderly with MCI, and 2) to investigate the effects of 6-month Tai Chi exercise on serum biomarkers in individuals with MCI.
Detailed Description
Mild Cognitive Impairment (MCI) is a transitional stage before converting from normal aging to dementia. Older adults with MCI are 10 times more likely to develop dementia than cognitively intact older adults. Thus, strategies that could deter the conversion from MCI to dementia will have significant impact on public health. There is growing interest in non-pharmacological approaches that could potentially slow down cognitive decline in late life. One such approach is the use of exercise to improve cognitive function. There is substantial evidence that exercise has benefits for cognitive function in elderly persons. Evidence on the benefits of exercise for cognition (either cognitive improvement or reduced cognitive decline) has been demonstrated through epidemiological studies, meta-analytical studies, and randomized controlled trials. Although exercise training holds promise for delaying the onset and slowing down the progression of cognitive impairment among elderly persons, most studies utilized aerobic-base exercise with relatively high intensity. High intensity aerobic exercise may not be practical for older people because they are likely to have physical limitations and/or co-morbid diseases.Thus, the effects of other forms of exercise particularly those that are less intense and well suited to elderly conditions should be examined. The moderating factors linking exercise training and cognitive improvement is yet to be further investigated. Tai Chi, a form of mind-body exercise, is a popular exercise among elderly. Although Tai Chi is considered as an aerobic exercise, the focus of this exercise in elders is not on cardiovascular fitness. It is characterized by slow, gentle motion and emphasized the conscious control of body movements. Several cognitive components including attention and mindfulness engage with physical movements during Tai Chi exercise. Thus, it is expected that Tai Chi exercise would have great benefit on cognition. Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of mild cognitive impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, Tai Chi, cognitive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Since no medication or other treatments are currently approved by Food and Drug Administration (FDA) for treatment of MCI, participants in the usual care group will not receive any form of treatment. They will receive an educational material about cognitive impairment. They will also be asked to maintain their daily routine.
Arm Title
Tai Chi exercise group
Arm Type
Experimental
Arm Description
The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down.
Intervention Type
Other
Intervention Name(s)
Tai Chi exercise
Intervention Description
The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down, The 10 forms Tai Chi will be used.
Primary Outcome Measure Information:
Title
Change from baseline in cognitive functions at 6 months
Description
memory, attention, executive function will be evaluated
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in serum biomarkers at 6 months
Description
inflammatory markers will be evaluated.
Time Frame
6 month
Title
Change from baseline in fall risk at 6 months
Description
Fall risk index will be evaluated using physiological profile approach (PPA)
Time Frame
6 months
Title
Change from baseline in quality of life at 6 months
Description
Health related quality of life will be evaluated using the Short Form 36 (SF-36) questionnaire.
Time Frame
6 months
Title
Change from baseline in cognitive functions at 3 months
Description
memory, attention, executive function will be evaluated
Time Frame
3 months
Title
Change from baseline in fall risk at 3 months
Description
Fall risk index will be evaluated using physiological profile approach (PPA)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis for MCI based on Petersen's criteria as follows: A self-reported memory complaint, corroborated by an informant interview A score on a standardized memory test rated as 0.5 on Clinical Dementia Rating (CDR) Normal general cognitive function, as determined by a clinician's judgment based on a structured interview with the patient and an informant report and adjusted Thai Mini-Mental State Examination (TMSE) 35 No or minimal impairment in activities of daily living (ADLs) or instrumental Activity of Daily Living (IADL), as determined by clinical review with the patients and informant interview Not sufficiently impaired, cognitively and functionally, to meet National Institute of Neurological and Communicative Disorders and Stroke/ Alzheimer's disease and Related Association (NINCDS-ADRDA) criteria for AD, as judged by an experienced AD clinician Presence of cognitive impairment determined by the score on the Montreal Cognitive Assessment (MoCA) lesser than 26 Comprehend instructions and willing to participate Exclusion Criteria: Presence of medical conditions that would be unsafe to exercise Presence of neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis) Presence of depressive symptoms, defined by the Geriatric Depression Scale (GDS)-Thai version 36 Presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease) Taking alcohol 6 hr before testing or using drug regimens that affect performance such as sedative and antidepressant. Exercise regularly (40-50 min/day at least 3 days/week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somporn Sungkarat, PhD
Organizational Affiliation
Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
City
Maung
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With MCI

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