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OpenTrials
Completed

NCT Number: NCT02730286

Activity Limitations in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

application of several standard instruments in patients with rheumatoid arthritis

Primary outcomes

  1. Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis

    Time frame: 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

  2. Model 2- Sequential Occupational Dexterity Assessment (SODA)

    Time frame: 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

  3. Model 3 and 4- SF-36=Short form health survey-36

    Time frame: 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.

  4. Model 5 - AIMS=Arthritis impact measurement scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Factors Associated With Activity Limitations in Individuals With Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 6, 2016
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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