NCT04690244

Brief 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. All participants had no practice Tai Chi Chuan before.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 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

June 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 21, 2020

Last Update Submit

December 26, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • Heart Rate Variability

    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

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

    10 weeks

  • 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

    10 weeks

  • 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)

    10 weeks

  • 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).

    10 weeks

  • 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).

    10 weeks

  • 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.

    10 weeks

  • 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.

    10 weeks

  • 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.

    10 weeks

Secondary Outcomes (2)

  • Weight Measurment

    10 weeks

  • Height Measurement

    10 weeks

Study Arms (2)

Tai Chi Chuan group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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

Tai Chi Chuan group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports University

Kaunas, 44221, Lithuania

Location

Study Officials

  • Rima Solianik, PhD

    Lithuanian Sport University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 30, 2020

Study Start

June 29, 2020

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations