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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690244
Other study ID # LithuanianSportsU-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 29, 2020
Est. completion date September 10, 2020

Study information

Verified date December 2020
Source Lithuanian Sports University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Lithuania Lithuanian Sports University Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Blood Pressure Resting blood pressure was measured using digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland) 10 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Weight Measurment Body weight was measured by Tanita Body Composition Analyzer TBF-300 (Japan). 10 weeks
Secondary Height Measurement The height was measured by a centimeter strip. 10 weeks
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