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NCT Number: NCT07592195

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Three-Ball Breathing Trainer, Patent Number:2021212828371

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.

Other names: Audio

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. BMI

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    Weight (kg) and height (m) will be combined and reported as BMI, expressed in kg/m²

  2. Body Composition

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    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.

  3. Symptom Checklist-90

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    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.

  4. Vital Capacity

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    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).

Other outcomes

  1. Blood pressure

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    Unit: mmHg; Abnormal value = Poor cardiovascular health

  2. Oxygen Saturation

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    The percentage of peripheral blood oxygen saturation measured using a pulse oximeter at rest. Used to assess the body's oxygenation status and respiratory efficiency. Unit: %

  3. Resting heart rate

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    The unit is "beats per minute (bpm)"; measurements are taken using standard heart rate monitoring equipment while the subject is at rest, and are used to assess baseline cardiovascular function.

  4. Peak expiratory flow

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    The peak expiratory flow rate, measured in liters per minute using a spirometer during a forced exhalation, directly reflects airway patency and respiratory muscle strength; a higher value indicates better respiratory function.

  5. Visual Analogue Scale for Drug Craving

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    Visual Analogue Scale for Drug Craving (VAS)Minimum score: 0, Maximum score: 10.Higher scores indicate more severe drug craving.

  6. Grip strength

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    Grip strength (kg): The maximum grip force measured using a handheld dynamometer, used to assess upper body strength.

  7. Back Scratch Test

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    Shoulder joint range of motion and upper limb flexibility are assessed by measuring the distance between the middle fingers when the hands are placed as close together as possible behind the back. The unit is centimeters (cm); a negative value indicates that the fingers overlap, while a positive value indicates that they do not overlap.

  8. Number of repetitions in the 30-second chair stand test

    Time frame: Baseline (Week 0), after the intervention (Week 9)

    The maximum number of times a person can stand up completely from a standard chair and sit back down within 30 seconds, used to assess lower limb function

Sponsors and collaborators

Lead sponsor

Southwest Medical University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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