Clinical trial NCT06516848: High-intensity Inspiratory Muscle Training in Patients With Asthma
Official title: High-intensity Inspiratory Muscle Training in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: inspiratory muscle training
exercises
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of high-intensity and low-intensity inspiratory muscle training added to the standard pulmonary rehabilitation exercise program including aerobic and peripheral muscle strengthening training on respiratory muscle function, exercise capacity, dyspnea and health-related quality of life in asthmatic patients. The aim of the study was to examine whether there are intra-group changes and inter-group differences in the groups where low and high intensity inspiratory muscle training was applied. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT).

Detailed description: Patients diagnosed with asthma by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT). Inspiratory muscle training will be carried out in the form of 2 minutes of work and 1 minute break for a total of 21 minutes, starting from 80% of the maximum inspiratory pressure determined by mouth pressure measurement for the H-IMT Group and 30% for the L-IMT Group. An 8-week training will be carried out by increasing the planned load by 5% every two weeks. In addition, breathing exercises, strengthening exercises and walking training on flat ground will be given to both groups in the form of a home program. The training program will be 8 weeks in total, 3 days a week. will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the smartphone. A total of 24 sessions will be held.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65 years
* 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)
* Those who were diagnosed at least 6 months ago and are under follow-up and treatment, and/or patients whose asthma is under control

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 (myasthenia gravis, muscular dystrophies, myopathies) that will prevent healthy respiratory function testing and rehabilitation.
* Having conditions such as cognitive dysfunction, mental retardation, dementia that make it difficult to implement the protocol or interpret the study results

Primary outcomes:
measure: Maximal inspiratory pressure (MIP) measurement
timeFrame: Change from baseline respiratory muscle strength at 8 weeks
measure: Six minute walking test
timeFrame: Change from baseline 6 minute walking distance at 8 weeks
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Change from baseline dyspnea perception at 8 weeks
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Change from baseline FVC at 8 weeks
measure: Forced Expiratory Volume (FEV1)
timeFrame: Change from baseline FEV1 at 8 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: Change from baseline PEF at 8 weeks]
measure: FEV1/FVC
timeFrame: Change from baseline FEV1/FVC at 8 weeks]
measure: Asthma Control Test (ACQ)
timeFrame: Change from baseline ACQ score at 8 weeks
measure: Peripheral muscle strength
timeFrame: Change from baseline peripheral muscle strength at 8 weeks
measure: Asthma Quality of Life Scale (AQLQ)
timeFrame: Change from baseline AQLQ score at 8 weeks]
measure: St. George Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline SGRQ score at 8 weeks
measure: International Physical Activity Questionnaire- short form
timeFrame: Change from baseline physical activity level at 8 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Esra Pehli̇van
state: Üsküdar
Study officials:
References: