Effects of Traditional Martial Arts, Open and Locked Exercise on the Physical and Mental Health of Drug Users

July 9, 2024 updated by: Guang Yang, Prof. Dr., Northeast Normal University
The aim of this study is to discuss the efficacy of Chinese traditional martial arts in reducing drug addiction and improving the physical and mental health of drug addicts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Jilin
      • Changchun, Jilin, China, 130024
        • Chinese Center of Exercise Epidemiology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Normal mental state, able to understand and accept instructions
  • Drug users who have survived the detoxification period
  • Without major diseases

Exclusion Criteria:

  • Drug use for more than 2 years
  • Drug abusers who have entered a drug rehabilitation center more than once

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Locked exercise
All classes are held offline with professional instructors.
Behavioral: Locked exercise
All participants received a six-month intervention of 45 minutes once a day. All participants performed blocked aerobic exercise.
Experimental: Multiplayer open exercise
All classes are held offline with professional instructors.
Behavioral: Multiplayer open exercise
All participants received a six-month intervention in the form of a balloon game competition. The intervention consisted of two phases: the first month consisted of a movement learning and consolidation phase of 45 minutes per session, once a day; the second five months consisted of a formal competition phase of 45 minutes per session, once a day. In the first phase, coaches taught participants the technical movements and rules. In the second phase, participants competed in groups during each session, with the coaches acting as referees.
No Intervention: Control group
Disseminating knowledge about the dangers of drugs
Experimental: Health Qigong - 12-Step Daoyin Health Preservation Exercises
All classes are conducted offline and are implemented by professional Health Qigong instructors.
Behavioral: Health Qigong - 12-Step Daoyin Health Preservation Exercises
All participants received a six-month intervention consisting of two phases: the first month was a movement learning and consolidation phase of 45 minutes per session, once a day; the second five months were a formal practice phase of 45 minutes per session, once a day. In the first phase, participants learn four new movements per session and consolidate these exercises in the next session. After learning all the movements, the remaining time of the first phase was used to consolidate the exercises. In the second phase, participants perform a full Health Qigong - 12-Step Daoyin Health Preservation Exercises practice in each session.
Experimental: Health Qigong - 12-Step Daoyin Health Preservation Exercises combined with locked exercise
All classes are held offline with professional instructors.
Behavioral: Health Qigong - 12-Step Daoyin Health Preservation Exercises combined with locked exercise
All participants received the intervention for six months, 45 minutes each time, once a day. All participants performed blocked exercise followed by Health Qigong - 12-Step Daoyin Health Preservation Exercises. The schedule was consistent with the Health Qigong - 12-Step Daoyin Health Preservation Exercises group and the Blocked Exercise group.
Experimental: Health Qigong - 12-Step Daoyin Health Preservation Exercises combined with open exercise
All classes are held offline with professional instructors.
Behavioral: Health Qigong - 12-Step Daoyin Health Preservation Exercises combined with open exercise
All participants received the intervention for six months, 45 minutes each time, once a day. All participants performed multiplayer Open Exercise followed by Health Qigong - 12-Step Daoyin Health Preservation Exercises exercises. The schedule was consistent with the Health Qigong - 12-Step Daoyin Health Preservation Exercises group and the Multiplayer Open Exercise group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in participants.
Time Frame: Month 6
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 6 months.
Month 6
Using a step test to test participants' aerobic endurance.
Time Frame: Month 6
Participants will undergo an aerobic endurance test before and after the intervention to assess the change in aerobic endurance from baseline at 6 months.
Month 6
The participants' flexibility was tested by seated forward bending.
Time Frame: Month 6
Participants will receive a seated forward bend test before and after the intervention to assess changes in flexibility from baseline at 6 months.
Month 6
The participants reaction abilities were tested by means of a reaction time tester.
Time Frame: Month 6
Participants will receive a response time test before and after the intervention to assess the change in responsiveness from baseline at 6 months.
Month 6
The balance ability of the participants was tested through a one-legged standing test.
Time Frame: Month 6
Participants will receive a one-legged standing test before and after the intervention to assess the change in balance from baseline at 6 months.
Month 6
The core strength of the participants was tested through a sit-up test.
Time Frame: Month 6
Participants will undergo a sit-up test before and after the intervention to assess changes in core strength from baseline at 6 months.
Month 6
Using a spirometry tester to investigate changes in pulmonary capacity of the participants.
Time Frame: Month 6
Participants will receive a spirometry test (vital capacity, ml) before and after the intervention to assess the change in spirometry from baseline at 6 months.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northeast Normal 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCEE2024

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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