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Healthy AgingNCT04690244

The Effect of Tai Chi Chuan in Older Adults

A study testing Tai Chi Chuan trainings in people with Healthy Aging and Motor Learning, run by Lithuanian Sports University at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Motor Learning, Cognitive Function
What is being tested?
Tai Chi Chuan trainings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteLithuania
Study dates
29 Jun 2020to 10 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

  • Lithuanian Sports University

    Kaunas, 44221

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

Being tested
Tai Chi Chuan trainings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Chi Chuan trainingsOther

    10 weeks of Tai Chi Chuan practice by 6-year experienced training teacher, 2 times per week, 60 min per session.

Study groups in NCT04690244
Study groupRoleWhat they receive
Tai Chi Chuan groupExperimentalFifteen 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.
Receives: Other: Tai Chi Chuan trainings
Control groupNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Variability

    R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland) in laying position, in rest.

    Measured: 10 weeks

  2. Blood Pressure

    Resting blood pressure was measured using digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)

    Measured: 10 weeks

  3. Perceived Stress Scale - PSS-10

    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

    Measured: 10 weeks

  4. Hospital Anxiety and Depression Scale (HADS)

    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)

    Measured: 10 weeks

  5. Muscle circulatory BDNF Measurement

    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).

    Measured: 10 weeks

  6. Circulating Irisin Measurement

    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).

    Measured: 10 weeks

  7. Motor Learning Evaluation

    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.

    Measured: 10 weeks

  8. Cognitive Function Performance Evaluation

    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.

    Measured: 10 weeks

  9. Balance Evaluation

    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.

    Measured: 10 weeks

Secondary outcomes (2)

  1. Weight Measurment

    Body weight was measured by Tanita Body Composition Analyzer TBF-300 (Japan).

    Measured: 10 weeks

  2. Height Measurement

    The height was measured by a centimeter strip.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start29 Jun 2020
  3. Primary completion10 Sep 2020
  4. Study completion10 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690244
Sponsor's protocol ID
LithuanianSportsU-4
Status last verified
Dec 2020
First submitted
21 Dec 2020
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi Chuan trainings in people with Healthy Aging and Motor Learning, run by Lithuanian Sports University at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04690244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

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