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NCT Number: NCT06588959

6-minute Pegboard Ring Test in Patients With Scleroderma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Validity and reliability study

Other

Determination of strength, endurance and exercise capacity of the upper extremities is an important issue in scleroderma management. 6PBRT, which is one of the tests serving this purpose, has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma, but when the literature is reviewed, it is seen that 6PBRT has not been studied in patients with scleroderma. This study was planned as a non-interventional safety study. The study will investigate the validity and reliability of 6PBRT in patients with scleroderma. In this context, the test will be performed 2 times with a 1-hour rest break. 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. The level of dyspnea and fatigue and baseline values of heart rate will be checked before the second trial to ensure patients are stable. All assessments will be performed by the same physiotherapist.

Primary outcomes

  1. 6-Minute Pegboard and Ring Test

    Time frame: 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 outcomes

  1. Demographic and Clinical Data

    Time frame: baseline

    Information on age, height, body weight, body mass index, gender, educational status, occupation, medication use, exercise habits and disease will be evaluated.

  2. Extremity Muscle Strength Measurement

    Time frame: baseline

    Hand grip, elbow flexion, shoulder flexion and abduction muscle forces will be measured with a dynamometer.

  3. Respiratory muscle strength measurement

    Time frame: 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).

  4. Muscle Oxygen Saturation

    Time frame: baseline

    Participants upper extremity muscle oxygen saturation will be assessed during 6PBRT.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasemin Gedikli, MSc in PT

CONTACT

[email protected]

5067246602 ext. +90

Sponsors and collaborators

Lead sponsor

Yasemin GEDIKLI

Other

Collaborators

  • Scientific Research Projects

Registry information

Official study title

"Validity and Reliability of the 6-minute Pegboard Ring Test in Patients With Scleroderma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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