Inspiratory Muscle Training in Patients With Inflammatory Myopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJózef Piłsudski University of Physical Education

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Inspiratory Muscle Training (IMT)

    Behavioral

    Inspiratory 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

33 Participants
are divided into 1 treatment group
Group A: Inspiratory Muscle Training (IMT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months

Secondary outcomes

1

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.

Time frame
3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
2

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.

Time frame
3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
3

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.

Time frame
3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
4

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.

Time frame
3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months

Other outcomes

Sponsors and contacts

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