NCT05650983

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

November 8, 2022

Last Update Submit

December 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Month 3

  • using the executive functioning tests to investigate the improvement of physical exercise on executive function in heroin addicts,

    Participants will perform executive function test

    Month 3

Study Arms (2)

1.Aerobic exercise

EXPERIMENTAL

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.

Behavioral: Aerobic exercise; Resistance exercise

2.Resistance exercise

EXPERIMENTAL

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.

Behavioral: Aerobic exercise; Resistance exercise

Interventions

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.

1.Aerobic exercise2.Resistance exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence

You may not qualify if:

  • any major mental illness other than heroin addiction
  • any exercise taboo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Desk and Computer and Playground

Guangzhou, Guangdongsheng, 510500, China

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 14, 2022

Study Start

April 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations