Inspiratory Muscle Training in Patients With Inflammatory Myopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Idiopathic inflammatory myopathies (IIM) are rare autoimmune disorders characterized by progressive, symmetrical proximal muscle weakness, frequently affecting the respiratory muscles. Diaphragmatic dysfunction and reduced inspiratory muscle strength contribute to impaired ventilation, fatigue, and reduced exercise tolerance. While exercise training has proven beneficial in patients with various neuromuscular conditions, evidence regarding inspiratory muscle training (IMT) in IIM is lacking.

This pilot interventional study will prospectively evaluate the impact of a 3-month IMT program on respiratory and functional outcomes in patients with IIM. The intervention consists of daily inspiratory resistance training (30 breaths/day, 7 days/week) using the Threshold IMT device (Philips Respironics, USA). Training intensity is set at 30% of maximal inspiratory pressure (MIP) and adjusted progressively based on patient-reported exertion. Participants receive individualized instruction, follow-up phone consultations every 2 weeks, and record adherence in exercise diaries.

Assessments include inspiratory muscle strength (MIP measured with Powerbreathe KH2 and RP Check), spirometry (FEV1, FVC, FIVC, IRV), diaphragm ultrasound (mobility and thickness fraction), six-minute walk test (6MWT), fatigue assessment (Borg scale, Fatigue Severity Scale), and quality of life (SF-36). Outcomes will be measured 3 months before training, at baseline, after 3 months of training, and during extended follow-up (up to 6-12 months). The primary endpoint is change in MIP. Secondary endpoints include pulmonary function parameters, diaphragmatic function, exercise tolerance, fatigue, and health-related quality of life.

The study will be conducted in the Neurology Clinic of the Medical University of Warsaw (WUM). A total of 33 patients with IIM, diagnosed according to EULAR/ACR criteria, will be recruited. Inclusion requires age ≥18 and written informed consent. Exclusion criteria include cognitive impairment, acute respiratory infection, prior respiratory training, pneumothorax, pulmonary hypertension, or contraindications to IMT. This trial is expected to provide the first structured evidence on the role of IMT in improving functional status in patients with inflammatory myopathy, potentially guiding individualized rehabilitation strategies for this patient population.

Conditions

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Inflammatory Myopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-group, prospective pilot intervention study evaluating the effects of inspiratory muscle training on functional status in patients with inflammatory myopathy. All participants receive the same inspiratory muscle training program and are followed for 12 months

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Inspiratory Muscle Training (IMT)

Patients with inflammatory myopathy will perform a 3-month inspiratory muscle training (IMT) program using a threshold device (Philips Respironics Threshold IMT). Training will be home-based, preceded by individual instruction, and monitored through exercise diaries and follow-up phone consultations. Assessments will be performed before training, after 3 months, and during follow-up visits.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type 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.

Interventions

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Inspiratory Muscle Training (IMT)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of inflammatory myopathy according to EULAR/ACR criteria
* Age ≥ 18 years
* Stable clinical condition allowing participation in physical activity
* Ability to understand and follow instructions
* Written informed consent to participate in the study

Exclusion Criteria

* Cognitive impairment preventing proper exercise performance
* Current respiratory tract infection
* Previous respiratory muscle training within the last 12 months
* History of spontaneous pneumothorax
* Pulmonary hypertension
* Tympanic membrane rupture or other middle ear pathology
* Lack of voluntary and informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No