Inspiratory Muscle Training in Patients With Inflammatory Myopathy

NCT07274267 | Recruiting

• 1 other identifier: KB/91/2024
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Myopathies

Keywords

Inspiratory muscle training; Diaphragm ultrasound; Respiratory muscle strength; Exercise tolerance

Outcome Measures

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.

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

Secondary Outcomes (7)

• Change in Forced Vital Capacity (FVC)

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

• Change in Forced Expiratory Volume in 1 Second (FEV1)

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

• Change in diaphragm thickness

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

• Change in 6-Minute Walk Distance (6-Minute Walk Test)

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

• Change in perceived exertion (Borg Rating of Perceived Exertion)

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

Study Arms (1)

Inspiratory Muscle Training (IMT)

EXPERIMENTAL

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.

Behavioral: Inspiratory Muscle Training (IMT)

Interventions

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.

Inspiratory Muscle Training (IMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead

Study Sites (1)

University Clinical Center of the Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

Related Publications (3)

• Van Thillo A, Vulsteke JB, Van Assche D, Verschueren P, De Langhe E. Physical therapy in adult inflammatory myopathy patients: a systematic review. Clin Rheumatol. 2019 Aug;38(8):2039-2051. doi: 10.1007/s10067-019-04571-9. Epub 2019 May 21.

  PMID: 31115788 BACKGROUND

• Ashton C, Paramalingam S, Stevenson B, Brusch A, Needham M. Idiopathic inflammatory myopathies: a review. Intern Med J. 2021 Jun;51(6):845-852. doi: 10.1111/imj.15358.

  PMID: 34155760 BACKGROUND

• Lundberg IE, Miller FW, Tjarnlund A, Bottai M. Diagnosis and classification of idiopathic inflammatory myopathies. J Intern Med. 2016 Jul;280(1):39-51. doi: 10.1111/joim.12524.

  PMID: 27320359 BACKGROUND

Related Links

• Academy of Physical Education in Warsaw - institutional website

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Jan Sznajder, PhD

CONTACT

+48696994812; jan.sznajder@awf.edu.pl

Agnieszka Lewińska, PhD

CONTACT

+48790013404; agnieszka.lewinska@awf.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: August 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)