- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690244
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- 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
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-
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Kaunas, Lithuania, 44221
- Lithuanian Sports University
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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
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Tai Chi Chuan group
Fifteen healthy elderly subjects participated in 10 weeks of Tai Chi Chuan practice. Inclusion criteria were:
All participants were asked to not perform any sports activities while the research was ongoing. |
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
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).
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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.
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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.
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10 weeks
|
Secondary Outcome Measures
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.
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10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
June 29, 2020
Primary Completion (ACTUAL)
September 10, 2020
Study Completion (ACTUAL)
September 10, 2020
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 26, 2020
First Posted (ACTUAL)
December 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 26, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID 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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