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NCT Number: NCT06554132

Respiratory Muscle Strength and Aerobic Capacity in Scleroderma

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

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scleroderma Group

Other

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

Healthy group

Other

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

Primary outcomes

  1. Respiratory muscle strength assessment

    Time frame: 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 outcomes

  1. Aerobic capacity assessment

    Time frame: 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.

  2. Fatigue assessment

    Time frame: 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.

  3. Pulmonary function test

    Time frame: 5 minutes

    Pulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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