Effects of SARAH Protocol in Women With Rheumatoid Arthritis

NCT ID: NCT05375422

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-02-07

Brief 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).

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SARAH group

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.

Group Type: EXPERIMENTAL

SARAH

Intervention Type: OTHER

Set of exercises with components of muscle strengthening, range of motion gain and home exercises.

Educational intervention

Intervention Type: OTHER

Information related to joint protection, use of splints, assistive devices and other general advice, as needed.

Control group

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.

After 12 weeks, the control group will also be invited to perform the SARAH protocol exercises.

Group Type: ACTIVE_COMPARATOR

Educational intervention

Intervention Type: OTHER

Information related to joint protection, use of splints, assistive devices and other general advice, as needed.

Interventions

SARAH

Set of exercises with components of muscle strengthening, range of motion gain and home exercises.

Intervention Type: OTHER

Educational intervention

Information related to joint protection, use of splints, assistive devices and other general advice, as needed.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Espirito Santo

OTHER

Sponsor Role: lead

Responsible Party

Samira Tatiyama Miyamoto, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samira Tatiyama Miyamoto, PhD

Vitória, Espírito Santo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Samira T Miyamoto, PhD

Role: CONTACT

sa.miyamoto@hotmail.com

+55 27 997606447

Ludmila Forechi, PhD

Role: CONTACT

ludimilaforechi@yahoo.com.br

+55 21 998132300

Facility Contacts

Samira T Miyamoto, PhD

Role: primary

sa.miyamoto@hotmail.com

+55 27 997606447

Other Identifiers

FUEspiritoSanto03

Identifier Type: -

Identifier Source: org_study_id