NCT02270320

Brief Summary

Background: Promotion of cognitive functions of middle aged and older adults and prevention of dementia are important issues in the aging society. In recent years, studies have shown that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and older adults, but not studies have investigated the neural mechanisms. Therefore, the purposes of this research project are: (1) to investigate the effects of TCC exercise intervention on improving cognitive functions and motor functions in healthy middle-aged and older adults; (2) to investigate the effects of TCC intervention on improving the integrity of frontostriatal fiber tracts, and areas and intensity of brain activation while performing a switching task in healthy middle-aged and older adults. Methods: This project used the assessor-blind and randomized control clinical trial design. A total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to two groups: experimental and control groups. Experimental group will receive a 60-minute exercise program, three times per week for 12 weeks. Control group will receive a telephone consultation once every two weeks for 12 weeks. All participants will receive clinical neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor function tests, diffusion spectrum MR imaging, and functional MRI experiments before intervention, and at the end of intervention to realize the changes of cognitive function, motor function, integrity of neural tracts, and intensity and regions of functional activation while doing switching task of executive function in order to understand the cognitive effects and the neural mechanisms of TCC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

September 9, 2014

Last Update Submit

November 9, 2015

Conditions

Keywords

Tai Chi Chuancognitive functionmotor functionMRI

Outcome Measures

Primary Outcomes (9)

  • General cognitive function

    Cognitive score on Montreal Cognitive Assessment Taiwan version (MoCA) and Clinical Dementia Rating (CDR).

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Executive function

    Completed time (seconds) on Color Trail Test- Part 1\& 2, and number of errors from executive function task on Cambridge Neuropsychological Test Automated Battery (CANTAB).

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Motor strength

    Upper and lower limbs' muscle strength (kg) on handheld dynamometer, grip test, and to test lower limb strength by measuring the completed times in 30 seconds, chair rise test.

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Flexibility

    Flexibility score (cm) on scratch test, chair sit and reach test.

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Balance

    Balance time (seconds) on eyes opened one-leg stance test.

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Coordination

    Coordination time (seconds) on four square step test and "Timed Up and Go" test

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Endurance

    Walking distance (meters) on six-minute walking test.

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Physical activity level

    Physical activity score on "Physical Activity Scale for the Elderly" questionnaire.

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Memory function

    Memory score on Cambridge Neuropsychological Test Automated Battery (CANTAB).

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

Secondary Outcomes (2)

  • Brain functional activation

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

  • Brain structural integrity

    This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

Other Outcomes (4)

  • Handness

    This outcome will be assessed at baseline.

  • Footness

    This outcome will be assessed at baseline.

  • Emotion

    This outcome will be assessed at baseline.

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Control group will receive a telephone consultation once every two weeks for 12 weeks.

Physical activity

ACTIVE COMPARATOR

Experimental group will receive a 60-minute 24 forms Yang-style Tai Chi Chuan exercise program, three times per week for 12 weeks.

Behavioral: Physical activity

Interventions

The training is 24 forms Yang-style Tai Chi Chuan exercise, which will perform a 60-minute exercise program, three times per week for 12 weeks.

Physical activity

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age range between 50 - 85 years old.
  • education level \> 6 years or can read and speak Chinese
  • Montreal Cognitive Assessment Taiwan version (MoCA) score \>= 26
  • Clinical Dementia Rating (CDR) score = 0
  • right dominant hand

You may not qualify if:

  • any neurological diseases, ex stroke, Parkinson's disease, trauma, epilepsy
  • cardiac disease, cardiac infarction, angina, uncontrolled hypertension
  • spiritual disease, anxiety or depression (Geriatric Depression Scale 15-item short-form score \>= 8)
  • Daily ability need helps (instrumental activities of daily living, IADL has one item score= 0 or 1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pei-Fang Tang, PhD

    School and Graduate Institute of Physical Therapy College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School and Graduate Institute of Physical Therapy College of Medicine

Study Record Dates

First Submitted

September 9, 2014

First Posted

October 21, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations