A Study on the Effects of Breathing Exercises and Aerobic Exercise on the Health of Men in Drug Rehabilitation
11 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
- 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?
Тип исследования
Интервенционный
Регистрация (Оцененный)
90
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Luzhou, Китай, 646000
- Рекрутинг
- Yongtingli
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Контакт:
- Yongting Li
- Номер телефона: 18226377721
- Электронная почта: 18226377721@163.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
Другие имена:
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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of Life Scale for Drug Addicts
Временное ограничение: 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
Временное ограничение: 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.
|
Baseline (Week 0), after the intervention (Week 9)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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BMI
Временное ограничение: 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
Временное ограничение: 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.
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Baseline (Week 0), after the intervention (Week 9)
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Symptom Checklist-90
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Blood pressure
Временное ограничение: Baseline (Week 0), after the intervention (Week 9)
|
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
Временное ограничение: 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
Временное ограничение: 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.
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Baseline (Week 0), after the intervention (Week 9)
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Peak expiratory flow
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
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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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 апреля 2026 г.
Первичное завершение (Оцененный)
10 июня 2026 г.
Завершение исследования (Оцененный)
30 июня 2026 г.
Даты регистрации исследования
Первый отправленный
28 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 мая 2026 г.
Первый опубликованный (Действительный)
18 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 мая 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SWMUIRBTX-202603-0015
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .