The Effect of Tai Chi Chuan in Older Adults

December 26, 2020 updated by: Lithuanian Sports University

The Effect of Tai Chi Chuan on Cognitive and Motor Functions in Older Adults

30 healthy older participants were enrolled in the study and were randomly classified into two groups. In the experimental group (n = 15) participants received 10-week Tai Chi Chuan practice intervention, in the control group (n=15) participants were asked do not change their living habits in 10 weeks. All participants had no practice Tai Chi Chuan before.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants had to proceed with familiarization with cognitive function tests before all measurements and evaluation. Study protocol began in the early morning after overnight fasting (10.7 ± 4.7 h). Firstly, participants were asked to lay in the supine position for 15 minutes in rest to measure resting heart rate (HR) and heart rate variability (HRV) during the last 10 minutes and blood pressure afterward. Subsequently, participants completed PSS-10 and HADS questionnaires, and then a venous blood sample was taken for BDNF and irisin concentrations measurements. Then measurements of cognitive functions and motor learning were performed. After baseline assessments, participants were randomized to the experimental and control groups. The experimental group subjects (n=15; 13 women) participated in 10 weeks Tai Chi practice. In the control group, participants (n=15; 13 women) were instructed do not to engage in any additional sports practice. All tests and measurements were repeated after 10 weeks in the same order as it was at the beginning of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, 44221
        • Lithuanian Sports University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age from 60 years old;
  • voluntary participation in the study;
  • does not have chronic diseases or injuries that may affect physical activity,
  • does not have physical and mental disorders;
  • has no hearing impairment;
  • does not smoke;
  • does not use psychotropic substances;
  • pulse from 40 to 100 beats per minute at rest;
  • impaired or corrected vision;
  • blood pressure up to 139/89 mmHg at rest;
  • never had practice of Tai Chi Chuan

Exclusion Criteria:

  • persons suffering from: mental, oncological, cardiovascular, skeletal, muscular, respiratory disorders or diseases after physical exhaustion will not be invited to the study;
  • after surgery; injuries (in last 3 years);
  • contraindications to physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tai Chi Chuan group

Fifteen healthy elderly subjects participated in 10 weeks of Tai Chi Chuan practice. Inclusion criteria were:

  • aged 60 years and older;
  • sedentary behavior for at least 6 months;
  • no previous experience of Tai Chi Chuan practice;
  • good physical health determined by Physical Activity Readiness Questionnaire as - confirmed by medical history;
  • no cognitive impairments determined by baseline Mini-Mental State Examination score of ≥ 45.

All participants were asked to not perform any sports activities while the research was ongoing.
Other: Tai Chi Chuan trainings
10 weeks of Tai Chi Chuan practice by 6-year experienced training teacher, 2 times per week, 60 min per session.
NO_INTERVENTION: Control group
In the control group, fifteen subjects also had to meet the same criteria and did not perform any exercises or make changes in their daily living life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 10 weeks
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland) in laying position, in rest.
10 weeks
Blood Pressure
Time Frame: 10 weeks
Resting blood pressure was measured using digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)
10 weeks
Perceived Stress Scale - PSS-10
Time Frame: 10 weeks
The purpose of this scale is to assess the degree of stress in subjects' lives. It consists of questions about the frequency of feeling and thoughts during the past time period. Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often. The scores are obtained by reversing the scores on the four positive items:for example, 0=4, 1=3, 2=2, etc. and then summing across all items. Scores for the 10-item form range from 0 to 40,with higher scores indicating greater perceived stress
10 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 10 weeks
To determine the level of anxiety and depression of subjects was used HADS scale. The scale consists of totally 14questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression.The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal(borderline case); 11-21 = Abnormal (case)
10 weeks
Muscle circulatory BDNF Measurement
Time Frame: 10 weeks
Venous blood samples from the median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum. Samples were aliquoted and stored at -20°C until analysis. The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit(R&D Systems, Minneapolis, USA).
10 weeks
Circulating Irisin Measurement
Time Frame: 10 weeks
Venous blood samples from the median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum. Samples were aliquoted and stored at -80°C until analysis. The serum concentration of Irisin was measured using a competitive ELISA, immobilized antigen immunoassay kit (BioVendor R&D Systems, Brno, Czech Republic).
10 weeks
Motor Learning Evaluation
Time Frame: 10 weeks
The reaction time and velocity study will be measured with a DPA-1 analyzer. The DPA-1 device allows to study the reaction time, dynamic and kinematic characteristics of the movements.
10 weeks
Cognitive Function Performance Evaluation
Time Frame: 10 weeks
The Automated Neuropsychological Assessment Metrics computer program, which assesses a person's neuropsychological condition, will be used to assess cognitive function indicators. Evaluates areas of cognition that are related to brain executive function. The following tests will be used in the study: Simple reaction time, Two choice reaction time, Memory search, Mathematical processing, Code substitution - learning, Code substitution - delayed, Go / No-Go, Matching grids.
10 weeks
Balance Evaluation
Time Frame: 10 weeks
Balance measurement will be measured on a Kistler platform. The subjects' balance study evaluated static posturography using a force plate and computer equipment to record signals (KISTLER, Switzerland, Slimline System 9286). During the study, the subject stands on the force plate in four different positions.
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Measurment
Time Frame: 10 weeks
Body weight was measured by Tanita Body Composition Analyzer TBF-300 (Japan).
10 weeks
Height Measurement
Time Frame: 10 weeks
The height was measured by a centimeter strip.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian Sports University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rima Solianik, PhD, Lithuanian Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LithuanianSportsU-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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