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Respiratory Muscle Strength and Aerobic Capacity in Scleroderma

Investigation of Respiratory Muscle Strength and Aerobic Capacity in Patients With Scleroderma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06554132
Enrollment
15
Registered
2024-08-15
Start date
2024-08-20
Completion date
2024-10-30
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma

Keywords

Scleroderma, Respiratory muscle strength, Aerobic capacity

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

Interventions

OTHERScleroderma Group

Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.

Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.

Sponsors

Firat University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Being diagnosed with Ssk according to ACR/EULAR criteria * Stable medical treatment for 3 months

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strength assessment5 minutesRespiratory 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

MeasureTime frameDescription
Aerobic capacity assessment10 minutesAerobic 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 assessment2 minutesFatigue 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 test5 minutesPulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026