Activity Limitations in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Factors Associated With Activity Limitations in Individuals With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730286
• Other study ID #: MS ID#: AJOT/2015/017467
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: March 31, 2016
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Conselho Nacional de Saúde (CNS) /Resolution 466/12
• Study type: Observational

Clinical Trial Summary

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model.

Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.

Description:

The investigators used the ICF model to analyze factors reported to be associated with functioning and disability in individuals with RA, including dexterity fatigue, stiffness , pinch, handgrip, strength, range of motion (ROM) deficit, deformities , mental health, vitality, and pain .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age over 18 years,

• Clinical diagnosis rheumatic arthritis

• Mental competence by the Mini-Mental State Examination

Exclusion Criteria:-

• Had undergone upper limb surgery,

• Had an uncorrected visual deficit that could compromise functionality

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• observational study
application of several standard instruments in patients with rheumatoid arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis	The TEMPA is assessing the performance of the upper extremities and consists of eight standardized tasks. Scoring of the task analysis dimension ranges from zero to 150 (a score of zero indicates no disability). The TEMPA is scored according to the time required (in seconds) to complete each task; the higher the score, the greater the disability	up to thirty minutes	No
Primary	Model 2- Sequential Occupational Dexterity Assessment (SODA)	The SODA in patient population with RA score ranges from zero to 108 across these 12 tasks, has been validated for RA patients	up to thirty minutes	No
Primary	Model 3 and 4- SF-36=Short form health survey-36	The SF-36 has eight scales and a final score ranging from zero to 100 for each of the eight dimensions (a score of 100 represents the best state of health). The Brazilian Portuguese version of the SF-36 in patient population with RA has been demonstrated to be a reproducible and valid.	up to thirty minutes	No
Primary	Model 5 - AIMS=Arthritis impact measurement scale	The score ranges from zero to 10 (a score of 10 indicates the worst state of health) in patient population with RA. The Portuguese version of AIMS2 has been shown to be satisfactory	up to thirty minutes	No