Respiratory Muscle Strength and Aerobic Capacity in Scleroderma

NCT06554132 | Recruiting

• 1 other identifier: 2024/10-02
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Scleroderma

Keywords

Scleroderma; Respiratory muscle strength; Aerobic capacity

Outcome Measures

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.

  5 minutes

Secondary Outcomes (3)

• Aerobic capacity assessment

  10 minutes

• Fatigue assessment

  2 minutes

• Pulmonary function test

  5 minutes

Study Arms (2)

Scleroderma group

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

Other: Scleroderma Group

Healthy group

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

Other: Healthy group

Interventions

Scleroderma Group OTHER

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

Scleroderma group

Healthy group OTHER

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

Healthy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Firat University

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)