Activity Limitations in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02730286
• Lead Sponsor: Federal University of Minas Gerais

Brief 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.

Detailed 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 .

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-08
• Study Completion: 2010-08
• Status Verified: 2016-03
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Last Update Submitted: 2016-03-31
• Study First Posted: 2016-04-06
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis	up to thirty minutes	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
Model 2- Sequential Occupational Dexterity Assessment (SODA)	up to thirty minutes	The SODA in patient population with RA score ranges from zero to 108 across these 12 tasks, has been validated for RA patients
Model 3 and 4- SF-36=Short form health survey-36	up to thirty minutes	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.
Model 5 - AIMS=Arthritis impact measurement scale	up to thirty minutes	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