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

11 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  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?

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
      • Luzhou, Cina, 646000
        • Reclutamento
        • Yongtingli
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • Three-Ball Breathing Trainer
  • Patent Number：2021212828371
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • Audio
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • Three-Ball Breathing Trainer
  • Patent Number：2021212828371
Comportamentale: 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.
Altri nomi:
  • Audio

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life Scale for Drug Addicts
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
6-Minute Walk Test
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
BMI
Lasso di tempo: Baseline (Week 0), after the intervention (Week 9)
Weight (kg) and height (m) will be combined and reported as BMI, expressed in kg/m²
Baseline (Week 0), after the intervention (Week 9)
Body Composition
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Symptom Checklist-90
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Vital Capacity
Lasso di tempo: 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).
Baseline (Week 0), after the intervention (Week 9)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood pressure
Lasso di tempo: Baseline (Week 0), after the intervention (Week 9)
Unit: mmHg; Abnormal value = Poor cardiovascular health
Baseline (Week 0), after the intervention (Week 9)
Oxygen Saturation
Lasso di tempo: 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: %
Baseline (Week 0), after the intervention (Week 9)
Resting heart rate
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Peak expiratory flow
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Visual Analogue Scale for Drug Craving
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Grip strength
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Back Scratch Test
Lasso di tempo: 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.
Baseline (Week 0), after the intervention (Week 9)
Number of repetitions in the 30-second chair stand test
Lasso di tempo: 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
Baseline (Week 0), after the intervention (Week 9)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Southwest Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

10 giugno 2026

Completamento dello studio (Stimato)

30 giugno 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SWMUIRBTX-202603-0015

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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