About this trial
Inflammatory myopathies are rare autoimmune diseases leading to progressive muscle weakness, often including the respiratory muscles. This study aims to investigate whether inspiratory muscle training (IMT) using a threshold device can improve functional status in patients with inflammatory myopathy. Thirty-three patients will undergo a 3-month home-based IMT program with progressive resistance. Functional capacity, inspiratory muscle strength, lung function, diaphragmatic mobility, fatigue, and quality of life will be assessed at baseline and during follow-up. The primary hypothesis is that IMT will enhance inspiratory muscle strength and translate into better functional performance and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of inflammatory myopathy according to European Alliance of Associations for Rheumatology / American College of Rheumatology criteria
Age ≥ 18 years
Stable clinical condition allowing participation in physical activity
Ability to understand and follow instructions
Disqualifiers
Cognitive impairment preventing proper exercise performance
Current respiratory tract infection
Previous respiratory muscle training within the last 12 months
History of spontaneous pneumothorax
Trial design
Single group
Treatments tested in this trial
Inspiratory Muscle Training (IMT)
BehavioralInspiratory muscle training performed with a threshold loading device (Threshold IMT, Philips Respironics). Participants perform 30 breaths once daily, 7 days per week, for 3 months. The training load is set at 30% of maximal inspiratory pressure (MIP) and increased by 10% if the perceived exertion decreases on two consecutive training days. Participants receive individualized instruction and regular follow-up consultations (every 2 weeks) to adjust load and verify adherence.
Treatment groups
Trial outcomes
Primary outcomes
Change in maximal inspiratory pressure (MIP)
Maximal inspiratory pressure (MIP) measured at the mouth using Powerbreathe KH2 devices. Results are expressed in cmH₂O. Higher values indicate greater inspiratory muscle strength.
Secondary outcomes
Change in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) assessed by spirometry using the EasyOne spirometer (NDD Medical Technologies). Results are expressed in liters (L) and as percent of predicted values (% predicted). Higher values indicate better pulmonary function.
Change in Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 Second (FEV1) assessed by spirometry using the EasyOne spirometer (NDD Medical Technologies). Results are expressed in liters (L) and as percent of predicted values (% predicted). Higher values indicate better pulmonary function.
Change in diaphragm thickness
Diaphragm thickness assessed by ultrasound using a Philips Lumify linear probe. Thickness is measured in millimeters (mm) at end-expiration and end-inspiration. Diaphragm thickening fraction (%) may be calculated from inspiratory and expiratory thickness measurements.
Change in 6-Minute Walk Distance (6-Minute Walk Test)
Functional exercise capacity assessed by the 6-Minute Walk Test (6MWT), conducted on a 30 m corridor. The total distance walked in 6 minutes is recorded in meters. Greater distance indicates better functional exercise capacity.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.