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Recruiting NCT06961838

The Effect of Inspiratory Muscle Training With Substance Use Disorder

No phase Interventional Substance Abuse Disorder Exercise Pulmonary Function Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory muscle training programme, control group.
Who it may be relevant to
Registry conditions: Substance Abuse Disorder, Exercise, Pulmonary Function, Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other Inspiratory muscle training programme
    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.
  • Other control group
    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 outcome measures

  • Dyspnea [Time frame: 4 weeks]
  • Respiratory Functions (FEV1) [Time frame: 4 weeks]
  • Respiratory Functions (FVC) [Time frame: 4 weeks]
  • Respiratory Functions (FEV1/FVC) [Time frame: 4 weeks]
  • Respiratory Functions (FEF 25-75%) [Time frame: 4 weeks]
  • Respiratory Functions (PEF) [Time frame: 4 weeks]
  • Respiratory Muscle Strength [Time frame: 4 weeks]
  • Cough Capacity [Time frame: 4 weeks]
  • Functional exercise capacity [Time frame: 4 weeks]
Secondary outcome measures (3)
  • Penn Substance Craving Scale [Time frame: 4 weeks]
  • Health-related quality of life [Time frame: 4 weeks]
  • Anxiety and Depression [Time frame: 4 weeks]

Eligibility criteria

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).

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Üsküdar University — Istanbul

Publications

  • Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438. PMID 11359958
  • Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available. PMID 5772056
  • Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648. PMID 16936234

Identifiers

NCT: NCT06961838 · ÜsküdarÜ2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗