- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320066
IMT in Asthma: Activity, Coping, Self-Management (IMT in Asthma)
Reflections of Inspiratory Muscle Training on Patient Experiences in Asthma Rehabilitation
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esra PEHLİVAN, PhD
- Phone Number: +90 216 777 96 00
- Email: fztesrakambur@yahoo.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34890
- Recruiting
- Istanbul Esenyurt University
-
Contact:
- Cahidenur Koçak
- Phone Number: 05511812675
- Email: cahidekocak25@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between the ages of 18-65
- Having been diagnosed with severe persistent, non-allergic asthma by a pulmonologist in accordance with the Global Initiative for Asthma (GINA) guideline criteria,
- Patients with type 2 inflammation markers. According to accepted standards; peripheral eosinophils <150/µL and/or negative skin prick test and/or total IgE <30 kU/L
- Bronchodilator response (>12% or 200 mL improvement in FEV1% predicted following inhalation of 400 mg salbutamol)
- Diagnosis-follow-up period: Patients diagnosed at least 6 months prior, under follow-up and treatment, and/or with controlled asthma
- Having completed the pulmonary rehabilitation program
- Completion of 8 weeks of inspiratory muscle training (IMT)
- Patients who have read, understood, and signed the informed consent form
Exclusion Criteria:
- Having recently had a respiratory tract infection recently (within the last month),
- Having a smoking history of more than 10 pack-years or having a history of smoking within 6 months after quitting smoking
- Having received oral corticosteroid treatment in the last 4 weeks,
- Having a Body Mass Index >35,
- Eosinophilic Granulomatosis Polyangiitis (EGPA) and Allergic Bronchopulmonary Aspergillosis (ABPA),
- Vasculitis,
- History of malignancy,
- Pregnancy,
- Previous lung surgery, use of long-term oxygen therapy
- Having accompanying restrictive lung diseases (advanced kyphoscoliosis, ankylosing spondylitis) and neuromuscular diseases (myastania gravis, muscular dystrophies, myopathies) that will prevent healthy respiratory function testing and rehabilitation.
- Cognitive dysfunction, mental retardation, dementia, or other conditions that make it difficult to follow the protocol,
- Unwillingness to continue participating in the study,
- Communication difficulties or intellectual deficiencies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pulmonary Rehabilitation Group (PRGr)
Pulmonary Rehabilitation Group (PRGr) Participant selection for the study was conducted using a purposive sampling approach. All participants experienced inspiratory muscle training for a total of 3 days per week over 8 weeks, with 2 days per week via video conference and 1 day per week as part of a home program. All interviews will be conducted online via a video conference website and recorded using a digital voice recorder. The recorded data will be transcribed word for word in Turkish. |
Other: Telephone concept elicitation interview All interview questions are designed to be quite open-ended in order to determine participants' preferences in an unbiased manner (as much as possible). Additional questions will only be used when necessary to ensure that all relevant concepts are covered. Participants will be asked questions about the effects of inspirational muscle training they have previously experienced on their daily lives, coping strategies, and self-management processes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-reported experiences of inspiratory muscle training (IMT) assessed by semi-structured in-depth interviews (study-specific interview guide)
Time Frame: Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Semi-structured, in-depth, audio-recorded interviews will be conducted using a study-specific interview guide containing open-ended questions to investigate the effect of an 8-week inspiratory muscle training (IMT) program on the experiences of adults with severe persistent asthma.
Interviews will be conducted online and, when possible, in person or via telephone/video call.
Interviews are expected to last approximately 45-60 minutes.
Recordings will be transcribed verbatim in Turkish, supplemented with the researcher's field notes, and analyzed using thematic analysis.
|
Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
|
Experience of exercising using telerehabilitation assessed by semi-structured in-depth interviews (study-specific interview guide)
Time Frame: Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Semi-structured, in-depth, audio-recorded interviews will be conducted using a study-specific interview guide with open-ended questions to explore participants' experiences of exercising with telerehabilitation, including the perceived role of telerehabilitation in the learning process, and perceived advantages, limitations, and challenges from the participant's perspective.
Interviews will be conducted online and, when possible, in person or via telephone/video call.
Interviews are expected to last approximately 45-60 minutes.
Recordings will be transcribed verbatim in Turkish, supplemented with the researcher's field notes, and analyzed using thematic analysis.
|
Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
|
Changes in physical activity in daily life assessed by semi-structured in-depth interviews (study-specific interview guide)
Time Frame: Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Semi-structured, in-depth, audio-recorded interviews will be conducted using a study-specific interview guide with open-ended questions to explore perceived changes in physical activity in daily life (e.g., walking, climbing stairs, housework) from the participant's perspective following the 8-week program.
Interviews will be conducted online and, when possible, in person or via telephone/video call.
Interviews are expected to last approximately 45-60 minutes.
Recordings will be transcribed verbatim in Turkish, supplemented with the researcher's field notes, and analyzed using thematic analysis.
|
Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
|
Self-management skills assessed by semi-structured in-depth interviews (study-specific interview guide)
Time Frame: Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Semi-structured, in-depth, audio-recorded interviews will be conducted using a study-specific interview guide with open-ended questions to explore participants' perceived self-management skills, including disease and trigger recognition, symptom monitoring, accountability/responsibility, and perceived control.
Interviews will be conducted online and, when possible, in person or via telephone/video call.
Interviews are expected to last approximately 45-60 minutes.
Recordings will be transcribed verbatim in Turkish, supplemented with the researcher's field notes, and analyzed using thematic analysis.
|
Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
|
Coping strategies assessed by semi-structured in-depth interviews (study-specific interview guide)
Time Frame: Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Semi-structured, in-depth, audio-recorded interviews will be conducted using a study-specific interview guide with open-ended questions to explore participants' perceived coping strategies, including breathing/respiratory rate control strategies and emotional and behavioral regulation during symptom attacks and when anxiety/panic symptoms are prominent.
Interviews will be conducted online and, when possible, in person or via telephone/video call.
Interviews are expected to last approximately 45-60 minutes.
Recordings will be transcribed verbatim in Turkish, supplemented with the researcher's field notes, and analyzed using thematic analysis.
|
Single assessment after completion of the 8-week IMT program (within 4 weeks after IMT completion)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMT_Asthma_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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