NCT07320066

Brief Summary

The aim of this study is to investigate asthma patients' experiences with an 8 week IMT and the perceived effects of this intervention on physical activity, coping strategies, and asthma self-management. A qualitative methodological design will be applied to understand the experiences of patients participating in the IMT program, how the program affected their daily activities, how they coped with symptoms and difficulties, and how they managed their condition.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

December 9, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

asthmainspiratory muscle trainingtelerehabilitationself-managementqualitative research

Outcome Measures

Primary Outcomes (5)

  • Patient-reported experiences of inspiratory muscle training (IMT) assessed by semi-structured in-depth interviews (study-specific interview guide)

    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)

    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)

    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)

    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)

    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)

Study Arms (1)

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: other

Interventions

otherOTHER

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.

Pulmonary Rehabilitation Group (PRGr)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asthma

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Esenyurt University

Istanbul, Istanbul, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 6, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 19, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations