6-minute Pegboard Ring Test in Patients with Scleroderma
- Conditions
- Systemic Sclerosis (SSc)Scleroderma
- Interventions
- Other: validity and reliability study
- Registration Number
- NCT06588959
- Lead Sponsor
- Yasemin GEDIKLI
- Brief Summary
The aim of this observational study was to evaluate the reliability and validity of the 6-minute pegboard and ring test (6PBRT) in patients with systemic sclerosis. The main question it aims to answer is:
- Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients with systemic sclerosis? Participants will repeat the 6PBRT 2 times 1 hour apart. In addition, respiratory muscle strength (MIP-MEP), upper extremity muscle strength (hand dynanometer and hand-held dynanometer), muscle oxygen saturation (Moxy Monitor Device) will be evaluated.
- Detailed Description
Upper extremity functions are of great importance, especially activities of daily living. There are opinions that the impairment of the upper extremity in scleroderma is greater than that of the lower extremity and affects the functional status of individuals more. This activity limitation is related to many activities of daily living, including unsupported upper limb movements that lead to dyspnea and fatigue in patients with cardiopulmonary disease. Therefore, determining the strength, endurance and exercise capacity of the upper extremities is an important issue in scleroderma management. One of the tests that serves this purpose is the 6PBRT, which has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma.
It was planned as a non-interventional reliability study. The study will investigate the validity and reliability of 6PBRT in patients with scleroderma. In this context, a 1-hour rest break will be given after the first test. Dyspnea and fatigue will be assessed using the Borg scale and muscle oxygenation, heart rate and blood pressure will be recorded before and after 6PBRT. After the 1-hour rest period, the second trial of 6PBRT will be performed. The level of dyspnea and fatigue and initial values of heart rate will be checked before the second trial to ensure that patients are stable. All assessments will be performed by the same physiotherapist. In addition, participants will be assessed for respiratory muscle strength, upper limb muscle strength and muscle oxidation during the performance test.
The smallest sample size of the study was 40 subjects with a correlation coefficient of 0.95 between the two tests and 90% power at 95% confidence interval. 50 subjects are aimed to be recruited against a 20% drop-out risk. Shapiro-Wilk test and histogram plots will be used to check the normality of the data. Demographic and clinical characteristics of the participants will be reported using descriptive statistics. Two-way random effects and absolute agreement methods and intraclass correlation coefficient (ICC) will be used to assess test-retest reliability. Reliability strength will be interpreted as excellent for an ICC value \>0.90. The 95% Confidence Interval (95% CI) will be calculated to investigate measurement variability.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Being between the ages of 18-75
- 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria
- Being clinically stable
- Ability to adapt to tests (visual, cognitive, cooperative)
- Those with neurological and/or musculoskeletal problems that may affect the work
- Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking
- Presence of severe infection or sepsis
- Being diagnosed with a known additional rheumatologic disease
- Any stage of cancer
- Pregnant or breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with systemic sclerosis validity and reliability study -
- Primary Outcome Measures
Name Time Method 6-Minute Pegboard and Ring Test baseline It is used to assess upper extremity exercise capacity.The 6PBRT will be performed using a pegboard with two upper and lower pegs placed at and above the participants\' shoulder level (20 cm). During the test, participants will use both hands simultaneously to move 10 lightweight wooden rings from the lower pegs to the upper pegs. Then, they will move the rings from the top pegs back to the bottom pegs. This activity will continue for six minutes. The aim is to move as many rings as possible during the six minutes. The score will be reported as the number of rings moved simultaneously. Every minute participants will be given standardized verbal encouragement. Heart rate, blood pressure, respiratory frequency, dyspnea and fatigue will be evaluated according to the Modified Borg Scale before and after the test.
- Secondary Outcome Measures
Name Time Method Demographic and Clinical Data baseline Information on age, height, body weight, body mass index, gender, educational status, occupation, medication use, exercise habits and disease will be evaluated.
Extremity Muscle Strength Measurement baseline Hand grip, elbow flexion, shoulder flexion and abduction muscle forces will be measured with a dynamometer.
Respiratory muscle strength measurement baseline Intraoral pressure will be measured with a measuring instrument. They are easily applicable and simple measurements. Maximal voluntary inspiratory and expiratory pressures (MIP and MEP) are the most commonly used noninvasive method to measure respiratory muscle strength. It is based on Müller (maximal inspiration) and Valsalva (maximal expiration).
Muscle Oxygen Saturation baseline Participants upper extremity muscle oxygen saturation will be assessed during 6PBRT.
Trial Locations
- Locations (1)
Selcuk University
🇹🇷Konya, Selcuklu, Turkey