Effects of SARAH Protocol in Women With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Effects of the Strengthening and Stretching Protocol for Rheumatoid Arthritis in the Hands (SARAH) on Hand Function in Women With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375422
• Other study ID #: FUEspiritoSanto03
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: February 7, 2024

Study information

• Verified date: May 2022
• Source: Federal University of Espirito Santo
• Contact: Samira T Miyamoto, PhD
• Phone: +55 27 997606447
• Email: sa.miyamoto[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 7, 2024
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• SARAH
Set of exercises with components of muscle strengthening, range of motion gain and home exercises.
• Educational intervention
Information related to joint protection, use of splints, assistive devices and other general advice, as needed.

Locations

Country	Name	City	State
Brazil	Samira Tatiyama Miyamoto, PhD	Vitória	ES

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Espirito Santo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand function	Michigan Hand Outcomes Questionnaire. A total of 37 items assess six domains: general hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction with hand function. The participant must score each item using Likert-type scales ranging from 1 to 5.	3 months
Secondary	Pain inventory	Brief Pain Inventory. It classifies pain as mild when scored from 1 to 4, moderate when scored from 5 to 7, and severe when the participant selects values from 8 to 10 points.	3 months
Secondary	Hand grip strength	Hand dynamometer. The participant should press the dynamometer with maximum force for 3 seconds and rest for 60 seconds. All values must be recorded for later calculation of the average of three attempts.	3 months
Secondary	Healthy related quality of life	Euro Quality of Life Instrument-5D (EQ-5D). The questionnaire consists of questions about health and disease states, such as: mobility, personal care, usual activities, pain/discomfort, anxiety/depression, and each of these has three associated levels of severity, corresponding to no problems (level 1). ), some problems (level 2) and extreme problems (level 3) experienced or felt by the individual.	3 months
Secondary	Functional capacity	Health Assesment Questionnaire (HAQ). Eight categories with scores from 0 (no problem) to 3 (unable to do) per category. The score for each category appears at the highest number of any of its items, and the final HAQ score is the average of the scores for the eight categories.	3 months
Secondary	Disease activity	Disease Activity Score (DAS-28). The DAS-28 score can be interpreted on a categorical scale: it is indicative of disease remission values <2.6, light activity when it has a result between 2.6 and 3.2, moderate activity when values >3.2 to 5, 1 and high disease activity when the result is greater than 5.1.	3 months