Respiratory Muscle Strength and Aerobic Capacity in Scleroderma
- Conditions
- Scleroderma
- Interventions
- Other: Scleroderma GroupOther: Healthy group
- Registration Number
- NCT06554132
- Lead Sponsor
- Firat University
- Brief Summary
Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated
- Detailed Description
Scleroderma is a systemic connective tissue disease characterized by progressive thickening of the skin, the etiology of which has not been fully elucidated, in which microvascular damage, immune activation and fibrosis play a role. Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. The study will include 15 patients and 15 healthy individuals of the same age and gender. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 15
- Being diagnosed with Ssk according to ACR/EULAR criteria
- Stable medical treatment for 3 months
- Having a regular exercise habit (doing regular exercise at least once a week for the last 3 months)
- Comorbidity with another chronic disease that may affect aerobic capacity or respiratory muscle strength
- Having concomitant acute respiratory diseases
- Having a smoking habit
- History of orthopedic or neurologic disease in the lower extremities that may prevent cycling
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Scleroderma group Scleroderma Group Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue. Healthy group Healthy group Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.
- Primary Outcome Measures
Name Time Method Respiratory muscle strength assessment 5 minutes Respiratory muscle strength will be assessed with an intraoral pressure gauge. These are the intraoral pressures measured at maximal respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration. As a result, the patient is asked to maximally inspire against the closed airway and maintain this for 1-3 seconds. MEP, on the other hand, after maximal inspiration, the patient is asked to perform maximal expiration against the closed airway for 1-3 seconds.
- Secondary Outcome Measures
Name Time Method Aerobic capacity assessment 10 minutes Aerobic capacity will be assessed using exercise testing. VO2max will be assessed using the Cosmed FitMate Pro® (Cosmed, Italy). The FitMate Pro® includes a turbine flowmeter to measure ventilation and a galvanic fuel cell oxygen sensor to analyze the oxygen fraction in expired gases.
Fatigue assessment 2 minutes Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al. This scale includes 9 questions related to fatigue.
Pulmonary function test 5 minutes Pulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files.
Trial Locations
- Locations (1)
Songul Baglan Yentur
🇹🇷Elazığ, Turkey