A Study on the Effects of Breathing Exercises and Aerobic Exercise on the Health of Men in Drug Rehabilitation

NCT07592195 | Recruiting

• 1 other identifier: SWMUIRBTX-202603-0015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Disorders, Substance Related

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (Week 0), after the intervention (Week 9)

Secondary Outcomes (4)

• BMI

  Baseline (Week 0), after the intervention (Week 9)

• Body Composition

  Baseline (Week 0), after the intervention (Week 9)

• Symptom Checklist-90

  Baseline (Week 0), after the intervention (Week 9)

• Vital Capacity

  Baseline (Week 0), after the intervention (Week 9)

Other Outcomes (8)

• Blood pressure

  Baseline (Week 0), after the intervention (Week 9)

• Oxygen Saturation

  Baseline (Week 0), after the intervention (Week 9)

• Resting heart rate

  Baseline (Week 0), after the intervention (Week 9)

Study Arms (3)

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.

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.

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.

Device: Resistance Breathing Training; Behavioral: Aerobic Exercise

Interventions

Resistance Breathing Training DEVICE

Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes.

Also known as: Three-Ball Breathing Trainer, Patent Number：2021212828371

Joint Training Group; Resistance Breathing Training Group

Aerobic Exercise BEHAVIORAL

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.

Also known as: Audio

Aerobic Exercise Group; Joint Training Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southwest Medical University: lead

Study Sites (1)

Yongtingli

Luzhou, 646000, China

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 18, 2026
• Study Start: April 1, 2026
• Primary Completion: June 10, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)