The Effect of Inspiratory Muscle Training With Substance Use Disorder

NCT06961838 | Recruiting

• 1 other identifier: ÜsküdarÜ2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Abuse Disorder; Exercise; Pulmonary Function; Rehabilitation

Keywords

Substance Use Disorder; Exercise; Rehabilitation; Pulmonary Function; Muscle Training

Outcome Measures

Primary Outcomes (9)

• Dyspnea

  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).

  4 weeks

• Respiratory Functions (FEV1)

  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.

  4 weeks

• Respiratory Functions (FVC)

  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 weeks

• Respiratory Functions (FEV1/FVC)

  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.

  4 weeks

• Respiratory Functions (FEF 25-75%)

  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.

  4 weeks

• Respiratory Functions (PEF)

  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.

  4 weeks

• Respiratory Muscle Strength

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

  4 weeks

• Cough Capacity

  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.

  4 weeks

• Functional exercise capacity

  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.

  4 weeks

Secondary Outcomes (3)

• Penn Substance Craving Scale

  4 weeks

• Health-related quality of life

  4 weeks

• Anxiety and Depression

  4 weeks

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

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: Inspiratory muscle training programme

Control group

ACTIVE COMPARATOR

Individuals in the control group will continue their standard treatment.

Other: control group

Interventions

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.

Inspiratory muscle training group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Üsküdar University

Istanbul, Turkey, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Beyzanur D Research Assistant

CONTACT

+ (0216) 400 22 22; beyzanur.dikmenhosbas@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 8, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)