Respiratory Muscle Strength and Aerobic Capacity in Scleroderma
ConditionScleroderma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorFirat University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being diagnosed with Ssk according to ACR/EULAR criteria
Stable medical treatment for 3 months
Disqualifiers
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
Trial population
People who have not a chronic disease or othopedic disease will be included as Healthy controls
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Scleroderma Group
Other interventionScleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.
Healthy group
Other interventionHealthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Scleroderma group1 intervention
Group B: Healthy group1 intervention
Trial outcomes
Primary outcomes
1
Respiratory muscle strength assessment
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.
Time frame
5 minutesSecondary outcomes
1
Aerobic capacity assessment
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.
Time frame
10 minutes2
Fatigue assessment
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.
Time frame
2 minutes3
Pulmonary function test
Pulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files.
Time frame
5 minutesSponsors and contacts
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Source ClinicalTrials.gov