NCT02552329

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

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

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

January 16, 2014

Last Update Submit

July 27, 2016

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentTai Chicognitive functions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cognitive functions at 6 months

    memory, attention, executive function will be evaluated

    6 months

Secondary Outcomes (5)

  • Change from baseline in serum biomarkers at 6 months

    6 month

  • Change from baseline in fall risk at 6 months

    6 months

  • Change from baseline in quality of life at 6 months

    6 months

  • Change from baseline in cognitive functions at 3 months

    3 months

  • Change from baseline in fall risk at 3 months

    3 months

Study Arms (2)

Control group

NO INTERVENTION

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.

Tai Chi exercise group

EXPERIMENTAL

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.

Other: Tai Chi exercise

Interventions

Tai Chi exerciseOTHER

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.

Tai Chi exercise group

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Maung, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Somporn Sungkarat, PhD

    Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 16, 2014

First Posted

September 17, 2015

Study Start

December 1, 2013

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

July 28, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)