Effects of SARAH Protocol in Women With Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Feb 7, 2024
  • participants needed
    60
  • sponsor
    Federal University of Espirito Santo
Updated on 29 May 2022
antirheumatics

Summary

The aim of this randomized controlled trial is to analyze the effect of the SARAH protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (RA).

Description

The volunteers will be randomized between groups: control group (n=30), which will receive usual guidelines and the SARAH group (n=30), which will perform the SARAH protocol exercises (brazilian portuguese version) along with the usual guidelines. To participate in the research, patients must be diagnosed with RA using disease-modifying antirheumatic medication for at least 3 months, and age equal to or older to 18 years. Participants with incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE) will be excluded from the study. The participants will be evaluated before and after the intervention regarding the variables: hand function (Michigan Hand Outcomes Questionnaire), pain (Brief Pain Inventory), handgrip strength (Jamar® manual dynamometer), quality of life (Euro Quality of Life Instrument-5D), functional capacity (Health Assessment Questionnaire), RA disease activity (DAS28). The SARAH group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement. Patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings. A total of 4 face-to-face meetings will be held during the 3-month follow-up. The SARAH group and the control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines. The program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.

Details
Condition Rheumatoid Arthritis
Treatment educational intervention, SARAH
Clinical Study IdentifierNCT05375422
SponsorFederal University of Espirito Santo
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

patients must be diagnosed with RA
using disease-modifying antirheumatic medication for at least 3 months
over 18 years old

Exclusion Criteria

incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE)
diagnosis of another associated autoimmune disease
having undergone previous surgical procedures on the hands
having suffered a fracture in the joints of the upper limbs in the last six months
being a patient on the waiting list for orthopedic surgery of the upper limb
being pregnant
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