Chester Step Test: is It Effective in Scleroderma Patients?

NCT06859567 | Not Yet Recruiting DMC

• 1 other identifier: 2025/03-16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis (SSC) is a chronic autoimmune disease in which autoimmune features are associated with vascular manifestations. Patients with SSC experience many problems such as interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), heart failure, severe gastrointestinal tract (GIT) involvement and scleroderma renal crisis (SRC). Because of these problems, SSC patients may develop an abnormal pulmonary hemodynamic response during exercise. In this situation, measuring the aerobic capacity of SSC patients can be a useful tool for health promotion. There are many different methods for measuring aerobic capacity tests. The most commonly used aerobic capacity test in SSC patients is the 6-minute walk test (6 MWT). However, although the 6 MWT is a commonly used test, it has some disadvantages. Because SSC affects multiple organs, there are doubts about the 6 MWT's ability to accurately assess these diseases. These disadvantages of the 6MWT have led to the search for new tests. The Chester step test (CST) is a submaximal test and a good option to assess aerobic capacity. An adapted version of the CST for non-healthy individuals can be used to assess aerobic capacity. There are some studies conducted with CST. As a result of my research, no study evaluating CST in individuals with SSC was found.

Conditions

Systemic Sclerosis (SSc); Chester Step Test; 6 Minutes Walk Test

Keywords

Chester step test; Systemic Sclerosis; 6 minutes walk test; Modified Borg Scale

Outcome Measures

Primary Outcomes (1)

• Modified Borg Scale

  The modified Borg scale is a validated scale for subjective perception of dyspnea used with the 6MWT to confirm the degree of respiratory distress. Exercise intensity is determined by individualized measurement. The 2002 guidelines of the American Thoracic Society recommend the modified Borg scale as an adjunct to the 6MWT. This scale is a vertical scale measured from 0 to 10. Here 0 represents no symptoms and 10 represents maximum symptoms. In this study, the modified Borg scale will be used to rate dyspnea and leg fatigue. The Borg scale will be printed out and this printout will be used for patient enumeration. The patient will be told what the numbers from 0 to 10 on the Borg scale mean. After instructions have been given, the patient will be asked to rate dyspnea and leg fatigue before and after the test and the numbers will be recorded.

  up to 30 minutes

Study Arms (1)

Evaluated Group

ACTIVE COMPARATOR

6 minute walk test, Chester step test

Other: Evaluation

Interventions

Evaluation OTHER

Comparison of the 6-minute walk test and Chester step test, one of the aerobic capacity tests

Evaluated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Patients who can walk independently without an assistive device

You may not qualify if:

• Chronic obstructive pulmonary disease
• Myocardial infarction history
• Congestive heart failure
• Serious or unstable illness that may limit exercise tolerance
• Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
• Inability to perform the simplest level of the Chester step test
• Arthroplasty or major operations on knee and hip joints
• Uncontrolled hypertension
• Lack of ability to understand and implement all recommended procedures

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University

Merkez, Elâzığ, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Havvagül Doğan

CONTACT

+90 4242370000; havvvaguldogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 11, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)