Substance Abuse DisorderNCT06961838
The Effect of Inspiratory Muscle Training With Substance Use Disorder
A study testing Inspiratory muscle training programme in people with Substance Abuse Disorder and Exercise, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse Disorder, Exercise, Pulmonary Function
- What is being tested?
- Inspiratory muscle training programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Abuse Disorder, Exercise, Pulmonary Function, Rehabilitation
- Being tested
- Inspiratory muscle training programme, control group
- Keywords
- Substance Use Disorder, Exercise, Rehabilitation, Pulmonary Function, Muscle Training
- Medical subject headings
- Substance-Related Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training programmeOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Inspiratory muscle training programme |
| Control group | Active comparator | Individuals in the control group will continue their standard treatment. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Respiratory Muscle Strength
The respiratory muscle strength of the participants will be assessed by maximal inspiratory (MIP) and expiratory intraoral pressures (MEP).
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
Penn Substance Craving Scale
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.
Measured: 4 weeks
Health-related quality of life
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.
Measured: 4 weeks
Anxiety and Depression
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start3 Jul 2025
- Primary completion1 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur Dikmen, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961838
- Sponsor's protocol ID
- ÜsküdarÜ2025
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 11359958Black 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.
PubMed 5772056Laszlo 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.
PubMed 16936234
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT06961838
- Acronym / sponsor ID
- ÜsküdarÜ2025
- Conditions
- Substance Abuse Disorder, Exercise, Pulmonary Function, Rehabilitation
- Keywords
- Substance Use Disorder, Exercise, Rehabilitation, Pulmonary Function, Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Other: Inspiratory muscle training programmeIn 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 | Active comparator | Other: control groupIndividuals in the control group will continue their standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being older than 18 years
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle training programmeIn 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 group |
| control groupIndividuals 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. | Other | Control group |
Primary outcome
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).
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.
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.
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.
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.
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.
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).
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.
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.
3 secondary outcomes
Penn Substance Craving Scale
Time frame: 4 weeks
Health-related quality of life
Time frame: 4 weeks
Anxiety and Depression
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 11359958Sivasothy 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.
- Background: PubMed 5772056Black 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.
- Background: PubMed 16936234Laszlo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training programme in people with Substance Abuse Disorder and Exercise, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.