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Clinical Trials/NCT06554132
NCT06554132
Recruiting
N/A

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

Firat University1 site in 1 country15 target enrollmentAugust 20, 2024
ConditionsScleroderma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Scleroderma
Sponsor
Firat University
Enrollment
15
Locations
1
Primary Endpoint
Respiratory muscle strength assessment
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
October 30, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Firat University
Responsible Party
Principal Investigator
Principal Investigator

Songül Bağlan Yentür

Firat University

Firat University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Aerobic capacity assessment(10 minutes)
  • Fatigue assessment(2 minutes)
  • Pulmonary function test(5 minutes)

Study Sites (1)

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