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NCT Number: NCT06961838

The Effect of Inspiratory Muscle Training With Substance Use Disorder

The aim was to investigate the effectiveness of inspiratory muscle training on dyspnoea, pulmonary function, respiratory muscle strength, cough capacity, functional exercise capacity, substance craving, depression, anxiety and quality of life in individuals with substance use disorder.

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Key information

Conditions

Substance Abuse Disorder Behavior Chemically-Induced Disorders Exercise Mental Disorders Motor Activity Pulmonary Function Rehabilitation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar University

Istanbul, Turkey, Turkey (Türkiye)

Location status: Recruiting

About this study

In recent years, substance use has increased among young people in our country, and studies investigating the negative effects of substances on pulmonary health have also increased. It has been emphasized in the literature that the most appropriate features should be determined for the exercise program in the treatment of individuals with SUD. Although studies in the literature have reported that substance use affects respiratory functions and creates a restrictive or obstructive pattern, no study investigating the effects of inspiratory muscle training has been found in the literature. To our knowledge, this study is the first to examine the effects of inspiratory muscle training on respiratory function in individuals with SUD. In our study, it was assumed that inspiratory muscle training could be a simple and inexpensive technique to improve dyspnea, respiratory functions, respiratory muscle strength, cough capacity, and exercise capacity in individuals with SUD, reduce substance cravings, increase quality of life, and reduce depression and anxiety, thus making it suitable for routine clinical use. The aim was to examine the effectiveness of inspiratory muscle training on dyspnea, respiratory functions, respiratory muscle strength, functional exercise capacity, substance craving, anxiety, depression, and quality of life in individuals with substance use disorders.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being older than 18 years
  • Meeting the current Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for Substance Use Disorder
  • Receiving inpatient treatment
  • Substance use for more than one year
  • Being able to follow simple instructions
  • Not having any visual and auditory pathology
  • Being able to cooperate with the devices used.

Exclusion criteria

  • Failure to comply with the treatment and assessment program
  • Participation in a structured physiotherapy/exercise program in the last 6 months
  • Presence of current psychotic symptoms
  • Presence of any physical disability or medical problem
  • Presence of respiratory system problems such as asthma and tuberculosis and infectious health problems (e.g. HIV, hepatitis B).

Treatment and study plan

Inspiratory muscle training programme

Other

In addition to their standard treatment, individuals in the inspiratory muscle training group will participate in inspiratory muscle training for a total of 30 minutes with a threshold loading device (POWERbreathe®) for 15 minutes twice a day, 5 days a week for 4 weeks under the supervision of a physiotherapist.

Control Group

Other

Individuals in the control group will continue their standard treatment. No changes will be made in the medical treatments (type, dosage and frequency) of the individuals in both groups (the inspiratory muscle training group and the control group) during the study.

Primary outcomes

  1. Dyspnea

    Time frame: 4 weeks

    Participants' perceptions of dyspnoea in daily life will be assessed using the Modified Medical Research Council Scale (mMRC), which consists of five statements describing the full range of dyspnoea from none (Grade 0) to almost complete incapacity (Grade 4).

  2. Respiratory Functions (FEV1)

    Time frame: 4 weeks

    Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced expiratory volume in 1 second (FEV1) will be recorded.

  3. Respiratory Functions (FVC)

    Time frame: 4 weeks

    Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced vital capacity (FVC) will be recorded.

  4. Respiratory Functions (FEV1/FVC)

    Time frame: 4 weeks

    Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, FEV1/FVC ratio will be recorded.

  5. Respiratory Functions (FEF 25-75%)

    Time frame: 4 weeks

    Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced expiratory flow (FEF 25-75%) will be recorded.

  6. Respiratory Functions (PEF)

    Time frame: 4 weeks

    Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, peak expiratory flow (PEF) will be recorded.

  7. Respiratory Muscle Strength

    Time frame: 4 weeks

    The respiratory muscle strength of the participants will be assessed by maximal inspiratory (MIP) and expiratory intraoral pressures (MEP).

  8. Cough Capacity

    Time frame: 4 weeks

    Participants' peak cough flow will be measured using a Peak Flow Meter (The Mini-Wright Standard, Cartel Business Estate, Edinburgh Way, Harlow) while individuals are making a maximal cough effort after as deep an inspiration as possible.

  9. Functional exercise capacity

    Time frame: 4 weeks

    Functional exercise capacity will be assessed using the 6-Minute Walk Test (6-MWT) performed using standard protocols in accordance with American Thoracic Society guidelines.

Secondary outcomes

  1. Penn Substance Craving Scale

    Time frame: 4 weeks

    It is a 5-item self-report questionnaire developed to assess substance craving over the past week, including frequency, intensity, duration, urgency, and total craving. Each item is rated on a scale of 0 to 6, with a maximum total score of 30 for severe cravings.

  2. Health-related quality of life

    Time frame: 4 weeks

    Health-related quality of life will be assessed with the health-related quality of life Short Form 12 questionnaire. Information from all 12 items is used to calculate the physical component summary and the mental health component summary score. All scores are converted into a standardized score between 0-100. Higher scores indicate better health-related quality of life.

  3. Anxiety and Depression

    Time frame: 4 weeks

    Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire assessing levels of depression (7 items) and anxiety (7 items). Each item is rated on a 4-point Likert scale. Subscale scores were calculated by summing the subscale items (subscale scores range from 0-21), with higher scores indicating greater severity. It has been previously shown that HADS scores equal to or higher than 10 and 7 on the relevant anxiety and depression items, respectively, indicate clinical levels of anxiety and depression in the Turkish population.

Study contacts

Contact information is provided by the study sponsor or research team.

Beyzanur D Research Assistant

CONTACT

[email protected]

+ (0216) 400 22 22

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 5, 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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