Respiratory Muscle Training in Scleroderma

Not Applicable

Not yet recruiting

• Conditions: Scleroderma (Limited and Diffuse)

• Registration Number: NCT06684132
• Lead Sponsor: Firat University

Brief Summary

The aim of this study is to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by exercise test and VO2max. Dyspnea will be assessed with the Modified Medical Research Council Scale; fatigue with the Fatigue Severity Scale; quality of life with the Scleroderma Health Assessment Questionnaire; physical activity level with the International Physical Activity Scale - Short Form

Detailed Description

Inspiratory muscle training (IMT) is performed by inspiring against an external load provided by a device. It is easy to implement, low cost and can be easily integrated into rehabilitation programs. Pulmonary rehabilitation and inspiratory muscle training have been applied as an effective method in ILD. However, there are no studies investigating the effects of IMT in individuals with ILD. The aim of this study was to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life, aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. In the control group, only stretching, strengthening and posture exercises will be applied as a home program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by VO2max with exercise test. dyspnea will be assessed using the Modified Medical Research Council Scale; fatigue will be assessed using the Fatigue Severity Scale; quality of life will be assessed using the Scleroderma Health Assessment Questionnaire; physical activity level will be assessed using the International Physical Activity Scale - Short Form.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study Start: 2024-11-10
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-01-10
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18-65 years old
• Patients whose medical treatment has not changed in the last three months
• Patients who volunteered to participate in the study and were cooperative
• Literate patients
• Patients followed with a diagnosis of SSc

Exclusion Criteria

• Patients who are pregnant
• Patients with a diagnosis of malignancy
• Patients with other concomitant systemic inflammatory rheumatic diseases
• Patients with neurological, orthopedic or congenital problems that prevent physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength	up to 8 weeks	Respiratory muscle strength will be assessed with an intraoral pressure gauge. Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are commonly used non-invasive methods to determine respiratory muscle strength. These are intraoral pressures measured at maximum respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration.

Secondary Outcome Measures

Name	Time	Method
Fatigue	up to 8 weeks	Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al.