NCT03687944

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2019

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 26, 2018

Last Update Submit

September 14, 2021

Conditions

Keywords

Rheumatoid ArthritisUnsupported Upper Limb Exercise TestValidity

Outcome Measures

Primary Outcomes (1)

  • Unsupported Upper Limb Exercise Test

    Endurance test

    two week

Secondary Outcomes (1)

  • 6 minute pegboard and ring test

    one week

Interventions

Test-retest method and concurrent validity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with rheumatoid arthritis

You may qualify if:

  • Diagnosis of Rheumatoid Arthritis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kinikli, 20160, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ayse Ayan, Dr

    Antalya Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 27, 2018

Study Start

December 6, 2018

Primary Completion

April 15, 2019

Study Completion

April 27, 2019

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Data of individuals will be given in the spss program

Locations