NCT06307483

Brief Summary

The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

August 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

January 24, 2024

Last Update Submit

March 24, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Pittsburgh Sleep Quality Index

    With subscale scores ranging from 0 to 3, the PSQI assesses subjective sleep quality in the previous month and consists of seven items (sleep duration, sleep latency, sleeping medications, sleep disturbance, daytime dysfunction, sleep quality, and sleep efficiency). The total score of the PSQI, ranging from 0 to 21, is the sum of subscale scores, and the higher the scores, the lower the subjective quality of sleep.

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Heart rate variability (HRV)

    HRV, a non-invasive method used to evaluate the autonomic nervous system modulation on the cardiac sinus node, describes the oscillations between consecutive electrocardiogram R-R intervals. High levels of HRV indices are generally signs of efficient autonomic mechanisms that characterise a healthy individual, while low or reduced HRV often show an autonomic nervous system malfunction and may imply health impairment.

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Flow-mediated dilation (FMD)

    Flow-mediated dilation (FMD) can assess endothelium-dependent vasodilation, evaluating vascular elasticity and dilation function. Its mechanism involves inducing reactive hyperemia, increasing arterial blood flow, leading to elevated shear stress on the vessel wall, prompting endothelial cells to release NO, resulting in vasodilation. A normal FMD value is ≥7%; values \<4% indicate endothelial dysfunction.

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Cardiac Output (CO)

    Cardiac Output (CO) is a key indicator in echocardiographic examinations, used to measure the total volume of blood pumped by the heart per minute. This parameter reflects the efficiency of the heart's pumping action and the status of systemic blood circulation. The measurement of Cardiac Output is based on the volume of blood ejected by the heart with each beat (stroke volume) and the number of heartbeats per minute. Cardiac Output is typically expressed in liters per minute (L/min).

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Intima-Media Thickness (IMT)

    Intima-Media Thickness (IMT) is a significant indicator measured through carotid ultrasound examination, used to assess the thickness of the carotid artery wall. The measurement of IMT focuses on the distance between the intima and media layers of the carotid artery, serving as a key indicator of early changes in atherosclerosis.

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • The Berg Balance Scale(BBS)

    The BBS scale evaluates an individual's ability to maintain their balance while performing functional activities. It includes 14 items and each section is scored between 0 (worst) and 4 (best), and measures level of dependence/independence in positions such as standing from sitting, standing with feet together, standing in full balance position, balancing on one leg, as well as ability to change positions. High BBS score indicates good balance. Participants are classifed based on BBS score as high fall risk, balance disorder (0-20 points), moderate fall risk, acceptable balance (21-40 points), and low fall risk, good balance (41-56 points)

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • The 30-s Chair Stand Test

    In the 30-s CST, which assesses dynamic balance and physical ftness, the individual sits in the middle of a chair with seat height of 43 cm, with a straight back, feet fat on the foor, and arms crossed over the chest with hands at shoulder level. The test starts with the subject in this position at the "go" command. The number of times the patient rises to a full standing position without assistance in 30 s is recorded as the test score. A score of 5 indicates strength and 10 indicates both strength and endurance

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Lower limb muscle strength test

    Using the micro FET3 (HOGGAN, USA) to test lower limb muscle strength. The main muscles tested include the tibialis anterior, triceps surae, quadriceps femoris, hamstrings, and iliopsoas. Each muscle is tested twice, and the maximum value is recorded

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

Secondary Outcomes (19)

  • Body Fat Percentage

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Finger-Ring Test

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Hand Grip Strength

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • Upper and Lower Body Flexibility

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • The SARC-F scale

    This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months

  • +14 more secondary outcomes

Study Arms (3)

Taichi group

Participants in the Tai chi group were regular Tai chi practitioners who had practiced Tai chi for at least 3 months, at least three times a week for at least 30 minutes each time.

Behavioral: Taichi group

Exercise group

The subjects in the exercise group had regular exercise habits, and insisted on non-Tai chi exercise for at least 3 months, at least three times a week, at least 30 minutes each time.

Behavioral: Exercise group

Control group

The subjects in the control group were people without long-term exercise habits.

Interventions

Taichi groupBEHAVIORAL

Participants in the Tai chi group were regular Tai chi practitioners who had practiced Tai chi for at least 3 months, at least three times a week for at least 30 minutes each time.

Taichi group
Exercise groupBEHAVIORAL

The subjects in the exercise group had regular exercise habits, and insisted on non-Tai chi exercise for at least 3 months, at least three times a week, at least 30 minutes each time.

Exercise group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects were people of both sexes aged 20-79 years with long-term Tai chi practice habit or long-term exercise habit or no exercise habit.

You may qualify if:

  • Men and women aged 20-79 years.
  • People who practice Tai chi for a long time.
  • People with long-term exercise habits.
  • People who have no habit of exercising.

You may not qualify if:

  • People currently participating in other interventions (e.g., nutrition, psychological, exercise, health education).
  • People with cognitive impairment and movement disorders.
  • Cardiovascular and cerebrovascular events (physician-diagnosed heart disease, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.) in the past 6 months.
  • People with other serious chronic diseases, such as asthma, cancer, chronic heart failure, severe depression, or other mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Sport University

Beijing, China

Location

MeSH Terms

Conditions

Sleep Wake DisordersCardiovascular DiseasesHypertensionCognitive DysfunctionMetabolic Diseases

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersVascular DiseasesCognition DisordersNeurocognitive DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

March 12, 2024

Study Start

August 25, 2023

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations