Systemic Sclerosis (SSc)NCT06588959
6-minute Pegboard Ring Test in Patients With Scleroderma
An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Yasemin GEDIKLI at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis (SSc), Scleroderma
- What is being tested?
- validity and reliability study
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University
Konya, Selcuklu, 42250
Yasemin Gedikli, +905067246602, yasemin.gedikli@selcuk.edu.tr
About this study
Official title: "Validity and Reliability of the 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.
Read the 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.
- Conditions
- Systemic Sclerosis (SSc), Scleroderma
- Being tested
- validity and reliability study
- Keywords
- Exercise Test, Upper Extremity, arm exercise endurance
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validity and reliability studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with systemic sclerosis | Not described Receives: Other: validity and reliability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
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.
Measured: baseline
Extremity Muscle Strength Measurement
Hand grip, elbow flexion, shoulder flexion and abduction muscle forces will be measured with a dynamometer.
Measured: baseline
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).
Measured: baseline
Muscle Oxygen Saturation
Participants upper extremity muscle oxygen saturation will be assessed during 6PBRT.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasemin GEDIKLI
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Projects
- Responsible party
- Sponsor-investigator, Yasemin GEDIKLI, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588959
- Sponsor's protocol ID
- SelcukU-FTR-YG-01
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16738459de 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.
PubMed 28378937Calik-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.
PubMed 33985406Calderon LM, Pope JE. Scleroderma epidemiology update. Curr Opin Rheumatol. 2021 Mar 1;33(2):122-127. doi: 10.1097/BOR.0000000000000785.
PubMed 33481429Andrews 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.
PubMed 8602410Alkotob 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.
PubMed 16840399Ozsoy 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.
PubMed 34674474Chen 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.
PubMed 37162267Özcan 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Validity and Reliability of the 6-minute Pegboard Ring Test in Patients With Scleroderma
- ClinicalTrials.gov ID
- NCT06588959
- Acronym / sponsor ID
- SelcukU-FTR-YG-01
- Conditions
- Systemic Sclerosis (SSc), Scleroderma
- Keywords
- Exercise Test, Upper Extremity, arm exercise endurance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yasemin GEDIKLIUniversity, hospital or other
- Collaborators
- Scientific Research Projects
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with systemic sclerosis | – | Other: validity and reliability study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| validity and reliability studyDetermination 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. | Other | patients with systemic sclerosis |
Primary outcome
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.
4 secondary outcomes
Demographic and Clinical Data
Time frame: baseline
Extremity Muscle Strength Measurement
Time frame: baseline
Respiratory muscle strength measurement
Time frame: baseline
Muscle Oxygen Saturation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 16738459Zhan 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.
- Results publication: PubMed 28378937de 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.
- Results publication: PubMed 33985406Calik-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.
- Results publication: PubMed 33481429Calderon LM, Pope JE. Scleroderma epidemiology update. Curr Opin Rheumatol. 2021 Mar 1;33(2):122-127. doi: 10.1097/BOR.0000000000000785.
- Results publication: PubMed 8602410Andrews 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.
- Results publication: PubMed 16840399Alkotob 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.
- Results publication: PubMed 34674474Ozsoy 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.
- Results publication: PubMed 37162267Chen 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.
- Results publicationÖzcan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Yasemin GEDIKLI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Gedikli, MSc in PT (5067246602 ext. +90, yasemin.gedikli@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Pegboard and Ring Test (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588959, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.