Respiratory Muscle Strength and Aerobic Capacity in Scleroderma

Investigation of Respiratory Muscle Strength and Aerobic Capacity in Patients With 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

Study Overview

• Status: Recruiting
• Conditions: Scleroderma
• Intervention / Treatment: Other: Scleroderma Group; Other: Healthy group

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

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• Turkey
  • Elazığ, Turkey, 23100
    • Recruiting
    • Songul Baglan Yentur
    • Contact: Songul Baglan Yentur; Phone Number: 04242370000; Email: songulbaglan23@hotmail.com
    • Contact: Songul Baglan Yentur; Phone Number: +904242370000; Email: songulbaglan23@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

People who have not a chronic disease or othopedic disease will be included as Healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Scleroderma group; Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.	Other: Scleroderma Group; Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.
Healthy group; Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.	Other: Healthy group; Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes
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.	2 minutes
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.	5 minutes

Collaborators and Investigators

• Sponsor: Firat University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic capacity; Scleroderma; Respiratory muscle strength
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: 2024/10-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No