Effects of SARAH Protocol in Women With Rheumatoid Arthritis

NCT05375422 | Completed DMC

• 1 other identifier: FUEspiritoSanto03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study 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).

Conditions

Rheumatoid Arthritis

Keywords

exercise; hand; physical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain inventory

  3 months

• Hand grip strength

  3 months

• Healthy related quality of life

  3 months

• Functional capacity

  3 months

• Disease activity

  3 months

Study Arms (1)

SARAH group

EXPERIMENTAL

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.

Other: SARAH

Interventions

SARAH OTHER

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

SARAH group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women over 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Espirito Santo: lead

Study Sites (1)

Samira Tatiyama Miyamoto, PhD

Vitória, Espírito Santo, 29050-780, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: February 7, 2022
• Primary Completion: May 7, 2022
• Study Completion: February 7, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)