Rheumatoid ArthritisNCT03687944
Unsupported Upper Limb Exercise Test in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of upper extremity functionalities, strength and endurance of individuals with rheumatoid arthritis is important in terms of establishing treatment program and determining treatment results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Validity and reliability
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2018to 27 Apr 2019
- How long will I take part?
- 3 Months
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with rheumatoid arthritis
Who may be able to join
- Diagnosis of Rheumatoid Arthritis
Who cannot join
- People who are over 65 years of age, who have carpal tunnel syndrome and adherent capsule, who have undergone surgery for upper extremity, who are pregnant or can not cooperated will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity and Reliability of Unsupported Upper Limb Exercise Test in Individuals With Rheumatoid Arthritis
Evaluation of upper extremity functionalities, strength and endurance of individuals with rheumatoid arthritis is important in terms of establishing treatment program and determining treatment results. In the literature, Unsupported Upper Limb Exercise Test (UULEX) has been found to be a valid and reliable method for endurance of unsupported upper extremity in individuals with chronic obstructive pulmonary disease and is frequently used to evaluate endurance in these patients. However, there is no study on the validity and reliability of UULEX in patients with rheumatoid arthritis.The aim of this study was to determine whether the Unsupported Upper Limb Exercise Test (UULEX) is a valid and reliable method to evaluate the upper extremity endurance in individual with rheumatoid arthritis (RA). To study; a minimum of 70 individual with RA under the age of 65 who are diagnosed with RA and have no other disease affecting the upper extremity performance will be included in the rheumatology outpatient clinic.The patients with upper extremity pain that will affect the performance of the upper extremity will be excluded from the study.
The tests will be done after the demographic data of the individuals are taken. Tests will be applied to individuals before application. After each test, individuals will rest for 5 minutes to reduce the effect of fatigue. The tests will take approximately 30-40 minutes to complete. For test-retest reliability, UULEX will be reapplied after one week. For compliance validity of the UULEX, Disability Assessment Shoulder and Hand Questionnaire (DASH), Health Assessment Questionnaire (HAQ), 30 sec Push up-Pull test and 6 minute pegboard and ring test will be applied.
Read the detailed description
Unsupported Upper Limb Exercise Test (UULEX):Individual sit on the chair in a way that touches the wall with the lines of the UULEX. The tables of the UULEX contain 8 horizontal levels. Each level is 84 cm wide and 8 cm high. The distance between the level centers is 15 cm. The line below corresponds to the knee level of the participant. The individual moves the plastic bar, which has a weight of 0.2 kg, from the hips by holding the arms at the shoulder width and moves it to the different levels of the lines of the UULEX in front of it. Each movement starts at the hip joint and ends at the hip joint. After making the first level for two minutes, the upper levels are made in two minute. The beginning and end point of each level is the hip joint. The bar is removed until 30 movements per minute accompanied by a metronome (level up). When individuals reach their maximum height, the bar weighing 0.2 kg is replaced with a 0.5 kg weighted bar. This weight will continue to raise to the maximum height. The weight is then increased by 0.5 kg per minute to 2 kg. Individual is referred to the test to continue until symptom limitation.
Statistical Analyses:The data will be given as mean ± standard deviation (X ± SD). The Intraclass Correlation Coefficient (ICC) will be used to evaluate the reliability of the UULEX. For concurrent validity, the relationship of the 30 sec Push up-Pull Test, DASH, HAQ and the 6-peg board ring test will be evaluated with Pearson correlation analysis. In our study, 85% power was obtained in the design made with 5% type 1 error and at least 70 patients. p value will be taken as 0.05.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Validity and reliability
- Keywords
- Rheumatoid Arthritis, Unsupported Upper Limb Exercise Test, Validity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and reliabilityOther
Test-retest method and concurrent validity
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsupported Upper Limb Exercise Test
Endurance test
Measured: two week
Secondary outcomes (1)
6 minute pegboard and ring test
endurance test
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start6 Dec 2018
- Primary completion15 Apr 2019
- Study completion27 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin,PT, Pamukkale University
- Investigators
- Ayse Ayan, Dr, Study chair, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687944
- Sponsor's protocol ID
- 60116787-020/58593
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of individuals will be given in the spss program
Publications
Lima VP, Velloso M, Almeida FD, Carmona B, Ribeiro-Samora GA, Janaudis-Ferreira T. Test-retest reliability of the unsupported upper-limb exercise test (UULEX) and 6-min peg board ring test (6PBRT) in healthy adult individuals. Physiother Theory Pract. 2018 Oct;34(10):806-812. doi: 10.1080/09593985.2018.1425786. Epub 2018 Jan 19.
PubMed 29351493
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of Unsupported Upper Limb Exercise Test in Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03687944
- Acronym / sponsor ID
- 60116787-020/58593
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Unsupported Upper Limb Exercise Test, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 27 Apr 2019 (actual)
- First posted
- 27 Sep 2018 (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.
Evaluation of upper extremity functionalities, strength and endurance of individuals with rheumatoid arthritis is important in terms of establishing treatment program and determining treatment results. In the literature, Unsupported Upper Limb Exercise Test (UULEX) has been found to be a valid and reliable method for endurance of unsupported upper extremity in individuals with chronic obstructive pulmonary disease and is frequently used to evaluate endurance in these patients. However, there is no study on the validity and reliability of UULEX in patients with rheumatoid arthritis.The aim of this study was to determine whether the Unsupported Upper Limb Exercise Test (UULEX) is a valid and reliable method to evaluate the upper extremity endurance in individual with rheumatoid arthritis (RA). To study; a minimum of 70 individual with RA under the age of 65 who are diagnosed with RA and have no other disease affecting the upper extremity performance will be included in the rheumatology outpatient clinic.The patients with upper extremity pain that will affect the performance of the upper extremity will be excluded from the study.
The tests will be done after the demographic data of the individuals are taken. Tests will be applied to individuals before application. After each test, individuals will rest for 5 minutes to reduce the effect of fatigue. The tests will take approximately 30-40 minutes to complete. For test-retest reliability, UULEX will be reapplied after one week. For compliance validity of the UULEX, Disability Assessment Shoulder and Hand Questionnaire (DASH), Health Assessment Questionnaire (HAQ), 30 sec Push up-Pull test and 6 minute pegboard and ring test will be applied.
Detailed description
Unsupported Upper Limb Exercise Test (UULEX):Individual sit on the chair in a way that touches the wall with the lines of the UULEX. The tables of the UULEX contain 8 horizontal levels. Each level is 84 cm wide and 8 cm high. The distance between the level centers is 15 cm. The line below corresponds to the knee level of the participant. The individual moves the plastic bar, which has a weight of 0.2 kg, from the hips by holding the arms at the shoulder width and moves it to the different levels of the lines of the UULEX in front of it. Each movement starts at the hip joint and ends at the hip joint. After making the first level for two minutes, the upper levels are made in two minute. The beginning and end point of each level is the hip joint. The bar is removed until 30 movements per minute accompanied by a metronome (level up). When individuals reach their maximum height, the bar weighing 0.2 kg is replaced with a 0.5 kg weighted bar. This weight will continue to raise to the maximum height. The weight is then increased by 0.5 kg per minute to 2 kg. Individual is referred to the test to continue until symptom limitation.
Statistical Analyses:The data will be given as mean ± standard deviation (X ± SD). The Intraclass Correlation Coefficient (ICC) will be used to evaluate the reliability of the UULEX. For concurrent validity, the relationship of the 30 sec Push up-Pull Test, DASH, HAQ and the 6-peg board ring test will be evaluated with Pearson correlation analysis. In our study, 85% power was obtained in the design made with 5% type 1 error and at least 70 patients. p value will be taken as 0.05.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with rheumatoid arthritis
Key inclusion criteria (1 listed)
- Diagnosis of Rheumatoid Arthritis
Key exclusion criteria (1 listed)
- People who are over 65 years of age, who have carpal tunnel syndrome and adherent capsule, who have undergone surgery for upper extremity, who are pregnant or can not cooperated will not be included in the study.
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 reliabilityTest-retest method and concurrent validity | Other | – |
Primary outcome
Unsupported Upper Limb Exercise Test
Time frame: two week
Endurance test
1 secondary outcome
6 minute pegboard and ring test
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Results publication: PubMed 29351493Lima VP, Velloso M, Almeida FD, Carmona B, Ribeiro-Samora GA, Janaudis-Ferreira T. Test-retest reliability of the unsupported upper-limb exercise test (UULEX) and 6-min peg board ring test (6PBRT) in healthy adult individuals. Physiother Theory Pract. 2018 Oct;34(10):806-812. doi: 10.1080/09593985.2018.1425786. Epub 2018 Jan 19.
- Individual participant dataSharing planned: No. Data of individuals will be given in the spss program
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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.
Ayse Ayan, Dr study chair
Antalya Training and Research Hospital
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 Rheumatoid Arthritis, run by Pamukkale University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsupported Upper Limb Exercise Test (time frame: two week). 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 NCT03687944, which also lists 1 linked publication.
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 16 Sep 2021.