6-minute Pegboard Ring Test in Patients with Scleroderma

NCT06588959 | Not Yet Recruiting

• 1 other identifier: SelcukU-FTR-YG-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis (SSc); Scleroderma

Keywords

Exercise Test, Upper Extremity, arm exercise endurance

Outcome Measures

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.

  baseline

Secondary Outcomes (4)

• Demographic and Clinical Data

  baseline

• Extremity Muscle Strength Measurement

  baseline

• Respiratory muscle strength measurement

  baseline

• Muscle Oxygen Saturation

  baseline

Study Arms (1)

patients with systemic sclerosis

Other: validity and reliability study

Interventions

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.

patients with systemic sclerosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Being between the ages of 18-75
• To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria
• Being clinically stable
• Ability to adapt to tests (visual, cognitive, cooperative)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yasemin GEDIKLI: lead
• Scientific Research Projects: collaborator

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42250, Turkey (Türkiye)

Location

Related Publications (9)

• Zhan S, Cerny FJ, Gibbons WJ, Mador MJ, Wu YW. Development of an unsupported arm exercise test in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2006 May-Jun;26(3):180-7; discussion 188-90. doi: 10.1097/00008483-200605000-00013.

  PMID: 16738459 BACKGROUND

• de Oliveira NC, Portes LA, Pettersson H, Alexanderson H, Bostrom C. Aerobic and resistance exercise in systemic sclerosis: State of the art. Musculoskeletal Care. 2017 Dec;15(4):316-323. doi: 10.1002/msc.1185. Epub 2017 Apr 5.

  PMID: 28378937 BACKGROUND

• Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, Saglam M, Vardar-Yagli N, Sonbahar-Ulu H, Firat M, Arikan H, Kaya SB, Karakaya G. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022 Jul;59(7):1387-1395. doi: 10.1080/02770903.2021.1930040. Epub 2021 May 31.

  PMID: 33985406 BACKGROUND

• Calderon LM, Pope JE. Scleroderma epidemiology update. Curr Opin Rheumatol. 2021 Mar 1;33(2):122-127. doi: 10.1097/BOR.0000000000000785.

  PMID: 33481429 BACKGROUND

• Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.

  PMID: 8602410 BACKGROUND

• Alkotob ML, Soltani P, Sheatt MA, Katsetos MC, Rothfield N, Hager WD, Foley RJ, Silverman DI. Reduced exercise capacity and stress-induced pulmonary hypertension in patients with scleroderma. Chest. 2006 Jul;130(1):176-81. doi: 10.1378/chest.130.1.176.

  PMID: 16840399 BACKGROUND

• Ozsoy I, Ozcan Kahraman B, Ozsoy G, Ilcin N, Kahraman T, Acar S, Tekin N, Savci S. Determinants of the 6-minute pegboard and ring test as an unsupported upper-extremity exercise capacity measure in older adults with chronic obstructive pulmonary disease. Eur Geriatr Med. 2018 Dec;9(6):863-870. doi: 10.1007/s41999-018-0111-x. Epub 2018 Sep 25.

  PMID: 34674474 BACKGROUND

• Chen YT, Kruger G, Devine A, Khanna D, Murphy SL. Experiences of Exergaming for Upper Extremity Exercises in People With Systemic Sclerosis. OTJR (Thorofare N J). 2023 Oct;43(4):665-675. doi: 10.1177/15394492231172934. Epub 2023 May 10.

  PMID: 37162267 BACKGROUND

• Özcan Kahraman B, Özsoy İ, Tanrıverdi A, Akdeniz B, Özpelit E, Şentürk B, Acar S, Sevinç C, Savcı S. VALIDITY AND RELIABILITY OF THE 6-MINUTE PEGBOARD RING TEST IN PATIENTS WITH PULMONARY HYPERTENSION. Turk J Physiother Rehabil. 2020;31(2):210-7.

  BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yasemin Gedikli, MSc in PT

CONTACT

5067246602; yasemin.gedikli@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Health Sciences Physiotherapy and Rehabilitation- Research assistant

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: October 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)