Respiratory Muscle Training in Scleroderma

ConditionScleroderma (Limited and Diffuse)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFirat University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Inspiratory muscle training
Other intervention
The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes.
Exercise
Other intervention
Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: IMT groupExperimental treatment 1 intervention

Group B: Exercise groupOther 1 intervention

Trial outcomes

Primary outcomes

Respiratory muscle strength

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.

Time frame

up to 8 weeks

Secondary outcomes

Fatigue

Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al.

Time frame

up to 8 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Firat University

Lead sponsor

Source ClinicalTrials.gov

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