Skip to content

Effects of SARAH Protocol in Women With Rheumatoid Arthritis

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375422
Enrollment
6
Registered
2022-05-16
Start date
2022-02-07
Completion date
2024-02-07
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

exercise, hand, physical therapy

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).

Detailed description

The volunteers 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 program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.

Interventions

OTHERSARAH

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

Sponsors

Federal University of Espirito Santo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hand function3 monthsMichigan 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.

Secondary

MeasureTime frameDescription
Pain inventory3 monthsBrief 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.
Hand grip strength3 monthsHand 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.
Healthy related quality of life3 monthsEuro 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.
Functional capacity3 monthsHealth 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.
Disease activity3 monthsDisease 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026