Disorders, Substance RelatedNCT07592195
A Study on the Effects of Breathing Exercises and Aerobic Exercise on the Health of Men in Drug Rehabilitation
A study testing Resistance Breathing Training and Aerobic Exercise in people with Disorders, Substance Related, run by Southwest Medical University at 1 site in China.
Trial summary
This study aims to investigate the effects of an 8-week combined exercise program on male individuals in drug rehabilitation. The program integrates resistance-based breathing training with aerobic exercise. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disorders, Substance Related
- What is being tested?
- Resistance Breathing Training and Aerobic Exercise
- Type of treatment
- Medical device, 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 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 18 to 50 years, able to understand and comply with the study protocol
- Meets the DSM-5 diagnostic criteria for substance use disorder; in rehabilitation for ≥1 month; withdrawal symptoms are stable (confirmed by medical staff)
- No severe cardiovascular/cerebrovascular disease, respiratory disease, musculoskeletal injury, or other contraindications to physical activity
- Basic reading and writing ability to independently complete questionnaire assessments
- Voluntarily signed informed consent and committed to complying with the 8-week training program
Who cannot join
- Presence of contraindications to exercise (e.g., recent fracture, severe arrhythmia, uncontrolled hypertension)
- Concurrent severe mental disorders (e.g., schizophrenia, acute depressive episode) or currently receiving unstable psychiatric medication
- Currently participating in other intervention studies or clinical trials
- Expected training compliance rate <70% (e.g., unable to complete the 8-week intervention due to transfer or disciplinary action)
- Unable to continue participation for personal reasons (e.g., early discharge, serious disciplinary violation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yongtingli
Luzhou, 646000
Yongting Li, 18226377721, 18226377721@163.com
About this study
Official title: A Study on the Effects of 8 Weeks of Resistance and Respiratory Training Combined With Aerobic Exercise on Physical Health and Quality of Life in Male Drug Rehabilitation Patients
This study aims to investigate the effects of an 8-week combined exercise program on male individuals in drug rehabilitation. The program integrates resistance-based breathing training with aerobic exercise. The investigators seek to determine whether this combined exercise program is more effective than a single form of exercise in improving participants' physical health and quality of life. The primary research questions to be addressed include: Does this combined exercise program produce better results than single-form training (resistance-based breathing training or aerobic exercise performed separately) in improving physiological indicators such as cardiopulmonary function and muscle strength in male individuals in drug rehabilitation? Does this combined exercise program yield greater benefits than single-form training in reducing anxiety and depression and improving quality of life among men in drug rehabilitation? This study will conduct a randomized controlled trial. Researchers will compare three different intervention groups-the combined training group, the resistance-breathing training group, and the aerobic exercise group-to verify the potential advantages of the combined program over single-form exercise. Participants will: Complete an 8-week exercise intervention, consisting of three sessions per week, each lasting approximately 40 minutes, under professional guidance and supervision. Undergo comprehensive assessments before and after the intervention, including cardiopulmonary function tests, body composition analysis, and questionnaires on mental health and quality of life.
Read the detailed description
- Exploration and Standardization of a Combined Exercise Program Tailored for Drug Rehabilitation Facilities. This section forms the foundation of the study and aims to develop an 8-week combined exercise program that is safe, effective, and easy to implement, specifically tailored to the environment and characteristics of residents in compulsory isolation drug rehabilitation centers. The content not only covers specific methods for integrating resistance-based breathing exercises with aerobic exercises (such as sequence, frequency, intensity, and duration) but also focuses on designing standardized operating procedures. These include concise instructions for participants, demonstration videos, key safety monitoring points (such as using the Borg Subjective Fatigue Scale or heart rate monitoring), and contingency plans for addressing common issues. The goal is to produce a "ready-to-use" guidebook that lays a solid foundation for subsequent implementation.
- Empirical Validation and Comparison of the Combined Exercise Program's Efficacy. This section constitutes the core of the study, aiming to empirically validate the actual effectiveness of this combined program for male individuals in the drug rehabilitation phase through a randomized controlled trial. Effectiveness evaluation will be entirely centered on the application objectives. It will primarily include: ① Physical Health: Focusing on verifying its effectiveness in improving areas of weakness among drug rehabilitation participants, such as cardiopulmonary function, muscle strength, and body composition; ② Mental Health and Quality of Life: Focusing on its positive impact on core rehabilitation goals such as anxiety and depression, sleep quality, and drug craving. The investigators will employ a controlled design with a combined-training group and a single-training group to address a key practical question: Does this combined program produce a "1+1>2" synergistic effect compared with single-modality resistance-breathing training or aerobic exercise, thereby offering greater practical value?
- Conditions
- Disorders, Substance Related
- Being tested
- Resistance Breathing Training, Aerobic Exercise
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Breathing TrainingDevice
Also called Three-Ball Breathing Trainer, Patent Number：2021212828371
Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes.
Aerobic ExerciseBehavioural
Also called Audio
Warm-up (5 minutes) → Main exercise (30 minutes, at 65%-85% of maximum heart rate or a Borg RPE score of 12-14) → Cool-down and stretching (5 minutes).During joint training sessions, each training session lasts 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Breathing Training Group | Experimental | Use a resistance breathing trainer and follow a progressive resistance training regimen, starting with low resistance and gradually increasing the intensity based on individual tolerance. Receives: Device: Resistance Breathing Training |
| Aerobic Exercise Group | Experimental | This session features moderate-intensity aerobic exercise, with intensity maintained at 60-70% of maximum heart rate, and includes a warm-up, main workout, and cool-down. Receives: Behavioral: Aerobic Exercise |
| Joint Training Group | Experimental | After the warm-up, start with 15 minutes of resistance breathing exercises, followed by 15 minutes of aerobic exercise, and then five minutes of stretching. Receives: Device: Resistance Breathing Training; Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale for Drug Addicts
Minimum score: 41, Maximum score: 205.Higher scores indicate worse quality of life and more severe impairment in physical, psychological, social, and withdrawal-related symptoms.
Measured: Baseline (Week 0), after the intervention (Week 9)
6-Minute Walk Test
The maximum distance a subject can cover in 6 minutes while walking at maximum speed along a 30-meter flat corridor. This test is used to assess cardiopulmonary function and exercise endurance during submaximal exercise.
Measured: Baseline (Week 0), after the intervention (Week 9)
Secondary outcomes (4)
BMI
Weight (kg) and height (m) will be combined and reported as BMI, expressed in kg/m²
Measured: Baseline (Week 0), after the intervention (Week 9)
Body Composition
Data was measured and analyzed using bioelectrical impedance analysis (BIA) with a body composition analyzer (MC-780MA, TANITA), including: body fat mass, skeletal muscle mass, body water, visceral fat, and basal metabolic rate.
Measured: Baseline (Week 0), after the intervention (Week 9)
Symptom Checklist-90
Symptom Checklist-90 (SCL-90); range 90-450; higher scores = worse mental health. Dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, sleep and eating.
Measured: Baseline (Week 0), after the intervention (Week 9)
Vital Capacity
A spirometer is used to measure the maximum volume of air a subject can exhale after taking a deep breath. This measurement is used to assess lung ventilation function. The unit of measurement is milliliters (mL).
Measured: Baseline (Week 0), after the intervention (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Apr 2026
- Primary completion10 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders, Substance RelatedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongting Li, Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592195
- Sponsor's protocol ID
- SWMUIRBTX-202603-0015
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of 8 Weeks of Resistance and Respiratory Training Combined With Aerobic Exercise on Physical Health and Quality of Life in Male Drug Rehabilitation Patients
- ClinicalTrials.gov ID
- NCT07592195
- Acronym / sponsor ID
- SWMUIRBTX-202603-0015
- Conditions
- Disorders, Substance Related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Southwest Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 May 2026 (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.
This study aims to investigate the effects of an 8-week combined exercise program on male individuals in drug rehabilitation. The program integrates resistance-based breathing training with aerobic exercise. The investigators seek to determine whether this combined exercise program is more effective than a single form of exercise in improving participants' physical health and quality of life. The primary research questions to be addressed include: Does this combined exercise program produce better results than single-form training (resistance-based breathing training or aerobic exercise performed separately) in improving physiological indicators such as cardiopulmonary function and muscle strength in male individuals in drug rehabilitation? Does this combined exercise program yield greater benefits than single-form training in reducing anxiety and depression and improving quality of life among men in drug rehabilitation? This study will conduct a randomized controlled trial. Researchers will compare three different intervention groups-the combined training group, the resistance-breathing training group, and the aerobic exercise group-to verify the potential advantages of the combined program over single-form exercise. Participants will: Complete an 8-week exercise intervention, consisting of three sessions per week, each lasting approximately 40 minutes, under professional guidance and supervision. Undergo comprehensive assessments before and after the intervention, including cardiopulmonary function tests, body composition analysis, and questionnaires on mental health and quality of life.
Detailed description
- Exploration and Standardization of a Combined Exercise Program Tailored for Drug Rehabilitation Facilities. This section forms the foundation of the study and aims to develop an 8-week combined exercise program that is safe, effective, and easy to implement, specifically tailored to the environment and characteristics of residents in compulsory isolation drug rehabilitation centers. The content not only covers specific methods for integrating resistance-based breathing exercises with aerobic exercises (such as sequence, frequency, intensity, and duration) but also focuses on designing standardized operating procedures. These include concise instructions for participants, demonstration videos, key safety monitoring points (such as using the Borg Subjective Fatigue Scale or heart rate monitoring), and contingency plans for addressing common issues. The goal is to produce a "ready-to-use" guidebook that lays a solid foundation for subsequent implementation.
- Empirical Validation and Comparison of the Combined Exercise Program's Efficacy. This section constitutes the core of the study, aiming to empirically validate the actual effectiveness of this combined program for male individuals in the drug rehabilitation phase through a randomized controlled trial. Effectiveness evaluation will be entirely centered on the application objectives. It will primarily include: ① Physical Health: Focusing on verifying its effectiveness in improving areas of weakness among drug rehabilitation participants, such as cardiopulmonary function, muscle strength, and body composition; ② Mental Health and Quality of Life: Focusing on its positive impact on core rehabilitation goals such as anxiety and depression, sleep quality, and drug craving. The investigators will employ a controlled design with a combined-training group and a single-training group to address a key practical question: Does this combined program produce a "1+1>2" synergistic effect compared with single-modality resistance-breathing training or aerobic exercise, thereby offering greater practical value?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Breathing Training Group | Experimental | Device: Resistance Breathing TrainingUse a resistance breathing trainer and follow a progressive resistance training regimen, starting with low resistance and gradually increasing the intensity based on individual tolerance. |
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic ExerciseThis session features moderate-intensity aerobic exercise, with intensity maintained at 60-70% of maximum heart rate, and includes a warm-up, main workout, and cool-down. |
| Joint Training Group | Experimental | Device: Resistance Breathing Training, Behavioral: Aerobic ExerciseAfter the warm-up, start with 15 minutes of resistance breathing exercises, followed by 15 minutes of aerobic exercise, and then five minutes of stretching. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male, aged 18 to 50 years, able to understand and comply with the study protocol
- Meets the DSM-5 diagnostic criteria for substance use disorder; in rehabilitation for ≥1 month; withdrawal symptoms are stable (confirmed by medical staff)
- No severe cardiovascular/cerebrovascular disease, respiratory disease, musculoskeletal injury, or other contraindications to physical activity
- Basic reading and writing ability to independently complete questionnaire assessments
- Voluntarily signed informed consent and committed to complying with the 8-week training program
Key exclusion criteria (5 listed)
- Presence of contraindications to exercise (e.g., recent fracture, severe arrhythmia, uncontrolled hypertension)
- Concurrent severe mental disorders (e.g., schizophrenia, acute depressive episode) or currently receiving unstable psychiatric medication
- Currently participating in other intervention studies or clinical trials
- Expected training compliance rate <70% (e.g., unable to complete the 8-week intervention due to transfer or disciplinary action)
- Unable to continue participation for personal reasons (e.g., early discharge, serious disciplinary violation)
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 |
|---|---|---|
| Resistance Breathing TrainingAlso: Three-Ball Breathing Trainer, Patent Number：2021212828371Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes. | Device | Joint Training Group, Resistance Breathing Training Group |
| Aerobic ExerciseAlso: AudioWarm-up (5 minutes) → Main exercise (30 minutes, at 65%-85% of maximum heart rate or a Borg RPE score of 12-14) → Cool-down and stretching (5 minutes).During joint training sessions, each training session lasts 15 minutes. | Behavioural | Aerobic Exercise Group, Joint Training Group |
Primary outcome
Quality of Life Scale for Drug Addicts
Time frame: Baseline (Week 0), after the intervention (Week 9)
Minimum score: 41, Maximum score: 205.Higher scores indicate worse quality of life and more severe impairment in physical, psychological, social, and withdrawal-related symptoms.
6-Minute Walk Test
Time frame: Baseline (Week 0), after the intervention (Week 9)
The maximum distance a subject can cover in 6 minutes while walking at maximum speed along a 30-meter flat corridor. This test is used to assess cardiopulmonary function and exercise endurance during submaximal exercise.
4 secondary outcomes
BMI
Time frame: Baseline (Week 0), after the intervention (Week 9)
Body Composition
Time frame: Baseline (Week 0), after the intervention (Week 9)
Symptom Checklist-90
Time frame: Baseline (Week 0), after the intervention (Week 9)
Vital Capacity
Time frame: Baseline (Week 0), after the intervention (Week 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Breathing Training and Aerobic Exercise in people with Disorders, Substance Related, run by Southwest Medical 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale for Drug Addicts (time frame: Baseline (Week 0), after the intervention (Week 9)). 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 18 May 2026.