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

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

Overview

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

1. 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. 2. 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?

Interventions

• Device Resistance Breathing Training
  Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes.
• Behavioral Aerobic Exercise
  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.

Primary outcome measures

• Quality of Life Scale for Drug Addicts [Time frame: Baseline (Week 0), after the intervention (Week 9)]
• 6-Minute Walk Test [Time frame: Baseline (Week 0), after the intervention (Week 9)]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Yongtingli — Luzhou

Identifiers

NCT: NCT07592195 · SWMUIRBTX-202603-0015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗