A Study on the Effects of Breathing Exercises and Aerobic Exercise on the Health of Men in Drug Rehabilitation
2026年5月11日 更新者：Yongting Li、Southwest Medical University
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.
調査の概要
詳細な説明
- 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?
研究の種類
介入
入学 (推定)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Luzhou、中国、646000
- 募集
- Yongtingli
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コンタクト：
- Yongting Li
- 電話番号：18226377721
- メール：18226377721@163.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Resistance Breathing Training Group
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.
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Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes.
他の名前：
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実験的：Aerobic Exercise Group
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.
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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.
他の名前：
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実験的：Joint Training Group
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.
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Warm-up (5 minutes) → Threshold resistance breathing trainer (30 minutes) → Cool-down stretches (5 minutes).During joint training, each session lasts 15 minutes.
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of Life Scale for Drug Addicts
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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6-Minute Walk Test
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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BMI
時間枠：Baseline (Week 0), after the intervention (Week 9)
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Weight (kg) and height (m) will be combined and reported as BMI, expressed in kg/m²
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Baseline (Week 0), after the intervention (Week 9)
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Body Composition
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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Symptom Checklist-90
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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Vital Capacity
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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).
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Baseline (Week 0), after the intervention (Week 9)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood pressure
時間枠：Baseline (Week 0), after the intervention (Week 9)
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Unit: mmHg; Abnormal value = Poor cardiovascular health
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Baseline (Week 0), after the intervention (Week 9)
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Oxygen Saturation
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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: %
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Baseline (Week 0), after the intervention (Week 9)
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Resting heart rate
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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Peak expiratory flow
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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Visual Analogue Scale for Drug Craving
時間枠：Baseline (Week 0), after the intervention (Week 9)
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Visual Analogue Scale for Drug Craving (VAS)Minimum score: 0, Maximum score: 10.Higher scores indicate more severe drug craving.
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Baseline (Week 0), after the intervention (Week 9)
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Grip strength
時間枠：Baseline (Week 0), after the intervention (Week 9)
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Grip strength (kg): The maximum grip force measured using a handheld dynamometer, used to assess upper body strength.
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Baseline (Week 0), after the intervention (Week 9)
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Back Scratch Test
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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.
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Baseline (Week 0), after the intervention (Week 9)
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Number of repetitions in the 30-second chair stand test
時間枠：Baseline (Week 0), after the intervention (Week 9)
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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
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Baseline (Week 0), after the intervention (Week 9)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月1日
一次修了 (推定)
2026年6月10日
研究の完了 (推定)
2026年6月30日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。