Health TrialsbyHealthPanel

6-minute Pegboard Ring Test in Patients With Scleroderma

ConditionsSystemic Sclerosis (SSc)Scleroderma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorYasemin GEDIKLI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

The study will be conducted at Selçuk University, Faculty of Health Sciences. The study will include volunteer individuals with systemic sclerosis who are eligible to participate in the study and who are being followed up and treated with a diagnosis of scleroderma in the Department of Rheumatology. \-- Purposive sampling

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • validity and reliability study

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: patients with systemic sclerosis1 intervention

Trial outcomes

Primary outcomes

1

6-Minute Pegboard and Ring Test

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.

Time frame
baseline

Secondary outcomes

1

Demographic and Clinical Data

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

Time frame
baseline
2

Extremity Muscle Strength Measurement

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

Time frame
baseline
3

Respiratory muscle strength measurement

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).

Time frame
baseline
4

Muscle Oxygen Saturation

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

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yasemin GEDIKLI

Lead sponsor

Selcuk University

Sponsor institution

Scientific Research Projects

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: