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Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts

Primary Purpose

Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease, Heroin Addicts, Executive Function

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aerobic exercise; Resistance exercise
Sponsored by
Guangzhou Sport University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence Exclusion Criteria: any major mental illness other than heroin addiction any exercise taboo

Sites / Locations

  • Desk and Computer and Playground

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1.Aerobic exercise

2.Resistance exercise

Arm Description

play balloon volleyball for Aerobic exercise and aimed at maximizing the strain on the cardiovascular system (60-70% of heart rate recovery). Aerobic exercise intervention five times a week, one hour each time,for three months.

Resistance strength training for Resistance exercise and aimed at promoting the greatest hypertrophy response(65% of 1 repetition maximum and repeated up to 15 times). Resistance exercise intervention five times a week, one hour each time,for three months.

Outcomes

Primary Outcome Measures

using the Symptom Checklist-90-R (SCL-90-R) questionnaire to investigate the improvement of physical exercise on psychological symptoms in heroin addicts,
Participants will be assessed the Symptom Checklist-90-R (SCL-90-R) questionnaire at pre and post exercise intervention.
using the executive functioning tests to investigate the improvement of physical exercise on executive function in heroin addicts,
Participants will perform executive function test

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
December 6, 2022
Sponsor
Guangzhou Sport University
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1. Study Identification

Unique Protocol Identification Number
NCT05650983
Brief Title
Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
Official Title
Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Sport University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this [type of study: exercise intervention study] is to test in describe participant health conditions. The main questions it aims to answer are: [Whether physical exercise improves executive function of male heroin addicts] [Whether physical exercise improves negative thinking/affect psychological experience of male heroin addicts] Participants will be randomly selected for medium-intensity strength training (resistance exercise,n=30), 30 will be selected for 1-hour long balloon volleyball sessions (aerobic exercise) at 60-70% volume of oxygen uptake during peak exercise, weekly 5 times for 12 weeks; and 30 will be assigned to the no-exercise control group, Participants will perform Executive function tests and the Symptom Checklist-90 Revised questionnaire at pre and post intervention. Researchers will compare resistance exercise group,aerobic exercise group and no-exercise control group to see if effects of exercise on executive function and negative thinking/affect psychological experience of male heroin addicts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease, Heroin Addicts, Executive Function, Negative Thinking/Affect

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.Aerobic exercise
Arm Type
Experimental
Arm Description
play balloon volleyball for Aerobic exercise and aimed at maximizing the strain on the cardiovascular system (60-70% of heart rate recovery). Aerobic exercise intervention five times a week, one hour each time,for three months.
Arm Title
2.Resistance exercise
Arm Type
Experimental
Arm Description
Resistance strength training for Resistance exercise and aimed at promoting the greatest hypertrophy response(65% of 1 repetition maximum and repeated up to 15 times). Resistance exercise intervention five times a week, one hour each time,for three months.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise; Resistance exercise
Intervention Description
To investigate affect/effect of dissimilar modes of exercise, Aerobic exercise versus Resistance exercise, on execution function and psychological symptoms in heroin addicts, 1 hour of characteristic exercise protocols aiming to (a) maximize the strain on the cardiovascular system with Aerobic exercise(60-70% of heart rate recovery) and (b) promote the greatest hypertrophy response with Resistance exercise(65% of 1 repetition maximum & repeated up to 15 time) were used. Both exercise programs were designed to match the male heroin addicts, with medium-intensity Strength-Trained for Resistance exercise and playing balloon volleyball for Aerobic exercise. Two exercise groups performed at 65% of their pre-determine peak oxygen uptake.
Primary Outcome Measure Information:
Title
using the Symptom Checklist-90-R (SCL-90-R) questionnaire to investigate the improvement of physical exercise on psychological symptoms in heroin addicts,
Description
Participants will be assessed the Symptom Checklist-90-R (SCL-90-R) questionnaire at pre and post exercise intervention.
Time Frame
Month 3
Title
using the executive functioning tests to investigate the improvement of physical exercise on executive function in heroin addicts,
Description
Participants will perform executive function test
Time Frame
Month 3

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence Exclusion Criteria: any major mental illness other than heroin addiction any exercise taboo
Facility Information:
Facility Name
Desk and Computer and Playground
City
Guangzhou
State/Province
Guangdongsheng
ZIP/Postal Code
510500
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts

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