High-intensity Inspiratory Muscle Training in Patients With Asthma
NCT Number: NCT06516848
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma
Interventions: OTHER: High Intensity Inspiratory Muscle Training Group (H-IMT)|OTHER: Low Intensity Inspiratory Muscle Training Group (L-IMT)
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2025-08-01
Locations: Esra Pehli̇van, İstanbul, Üsküdar, 34668, Turkey

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).

Primary Outcome Measures: Maximal inspiratory pressure (MIP) measurement, Respiratory muscle strength will be assessed via maximal inspiratory pressure (MIP). Tests will be carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria., Change from baseline respiratory muscle strength at 8 weeks|Six minute walking test, The exercise capacity will be assessed by the 6-minute walking test. The test will be conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines., Change from baseline 6 minute walking distance at 8 weeks|Modified Medical Research Council (mMRC) Dyspnea Scale, The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to evaluate the patients' dyspnea levels. The mMRC will consist of a 0-4 point category scale in which the patient will choose the statement that best describes their dyspnea level among 5 statements that express the feeling of difficulty in breathing experienced in daily life activities. A higher score will indicate greater dyspnea severity., Change from baseline dyspnea perception at 8 weeks
Secondary Outcome Measures: Forced Vital Capacity (FVC), Pulmonary function test will be performed using the Pony Fx spirometry device, according to the American Thoracic Society (ATS) guidelines. FVC is the volume of air that can forcibly be blown out after full inspiration., Change from baseline FVC at 8 weeks|Forced Expiratory Volume (FEV1), Change in Forced Expiratory Volume (FEV1) will be measured using spirometry as the maximal volume of air (liters) exhaled in the first second of expiration., Change from baseline FEV1 at 8 weeks|Peak Expiratory Flow (PEF), Change in Peak Expiratory Flow (PEF) will be measured using spirometry as the maximal speed of expiration (measured in liters/min)., Change from baseline PEF at 8 weeks]|FEV1/FVC, Spirometry will be used to measure the values of FEV1/FVC three times. The highest result will be recorded., Change from baseline FEV1/FVC at 8 weeks]|Asthma Control Test (ACQ), The ACQ will be a test that allows subjective evaluation of the last 4 weeks of disease control in asthma patients. The ACQ will consist of 5 items that the patient can complete themselves. Each item will be scored between 1 and 5. An ACQ score of 25 will indicate "controlled" asthma, a score between 20 and 24 will indicate "partially controlled" asthma, and a score \<20 will indicate "uncontrolled" asthma., Change from baseline ACQ score at 8 weeks|Peripheral muscle strength, Peripheral muscle strength will be assessed by a hand-held dynamometer., Change from baseline peripheral muscle strength at 8 weeks|Asthma Quality of Life Scale (AQLQ), This survey will consist of 32 questions in four disease-specific health areas. The AQLQ will include 12 questions about symptoms, 11 questions about limitations in activities, 5 questions about emotional state, and 4 questions about environmental stimuli. Patients will be asked to respond to each item on a 7-point scale (1: Severe impairment, 7: No impairment) considering their quality of life in the last two weeks. The total score average and average scores for sub-dimensions will be calculated. The average of the obtained values will be evaluated between 1 and 7., Change from baseline AQLQ score at 8 weeks]|St. George Respiratory Questionnaire (SGRQ), This will be a self-administered questionnaire that can be completed by the patient to determine disease-specific quality of life. The test will consist of 50 items divided into 3 parts measuring the symptoms of the disease, activity limitation, and social/emotional impact. The activity component will relate to physical activities that may cause or are limited by shortness of breath. The impact component will include factors such as work, occupation, medications taken to keep one's health under control, side effects of medications, difficulty in continuing daily life activities, and panic. The three parts of the test will be scored separately and the total score will be calculated. St. George Respiratory Questionnaire scores will range from 0 (no impairment in quality of life) to 100 (poor quality of life). In the SGRQ questionnaire, a change of four units due to treatment will be considered significant., Change from baseline SGRQ score at 8 weeks|International Physical Activity Questionnaire- short form, Physical activity level will be assessed by the International Physical Activity Questionnaire - Short Form. This will include seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities, and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week. MET values and formula for computation of MET-minutes: Walking MET-minutes/week = 3.3 \* walking minutes \* walking days; Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days; Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days. A combined total physical activity MET-min/week will be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores., Change from baseline physical activity level at 8 weeks