Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular DiseaseNCT05650983
Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
A study testing Aerobic exercise; Resistance exercise in people with Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease and Heroin Addicts, run by Guangzhou Sport University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease, Heroin Addicts, Executive Function
- What is being tested?
- Aerobic exercise; Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence
Who cannot join
- any major mental illness other than heroin addiction
- any exercise taboo
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease, Heroin Addicts, Executive Function, Negative Thinking/Affect
- Being tested
- Aerobic exercise; Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise; Resistance exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Aerobic exercise; Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunlu Fang, Guangzhou Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650983
- Sponsor's protocol ID
- 2022LcLL-30
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
- ClinicalTrials.gov ID
- NCT05650983
- Acronym / sponsor ID
- 2022LcLL-30
- Conditions
- Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease, Heroin Addicts, Executive Function, Negative Thinking/Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Guangzhou Sport UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Aerobic exercise | Experimental | Behavioral: Aerobic exercise; Resistance exerciseplay 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. |
| 2.Resistance exercise | Experimental | Behavioral: Aerobic exercise; Resistance exerciseResistance 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence
Key exclusion criteria (2 listed)
- any major mental illness other than heroin addiction
- any exercise taboo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise; Resistance exerciseTo 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. | Behavioural | 1.Aerobic exercise, 2.Resistance exercise |
Primary outcome
using the Symptom Checklist-90-R (SCL-90-R) questionnaire to investigate the improvement of physical exercise on psychological symptoms in heroin addicts,
Time frame: Month 3
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,
Time frame: Month 3
Participants will perform executive function test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise; Resistance exercise in people with Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease and Heroin Addicts, run by Guangzhou Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
using the Symptom Checklist-90-R (SCL-90-R) questionnaire to investigate the improvement of physical exercise on psychological symptoms in heroin addicts, (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.