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Clinical Trials/NCT06684132
NCT06684132
Not yet recruiting
Not Applicable

Effects of Respiratory Muscle Training in Patients With Scleroderma With Pulmonary Involvement

Firat University0 sites30 target enrollmentNovember 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scleroderma (Limited and Diffuse)
Sponsor
Firat University
Enrollment
30
Primary Endpoint
Respiratory muscle strength
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2024
End Date
February 20, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Firat University
Responsible Party
Principal Investigator
Principal Investigator

Songül Bağlan Yentür

Firat University

Firat University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Respiratory muscle strength

Time Frame: 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 Outcomes

  • Fatigue(up to 8 weeks)

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