The Effect of Inspiratory Muscle Training With Substance Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUskudar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory muscle training programme
Other interventionIn 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 interventionIndividuals 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Inspiratory muscle training groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
4 weeks2
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.
Time frame
4 weeks3
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.
Time frame
4 weeks4
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.
Time frame
4 weeksSecondary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
4 weeks3
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.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov