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Completed

NCT Number: NCT05375422

Effects of SARAH Protocol in Women With Rheumatoid Arthritis

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samira Tatiyama Miyamoto, PhD

Vitória, Espírito Santo, 29050-780, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SARAH

Other

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

Primary outcomes

  1. Hand function

    Time frame: 3 months

    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.

Secondary outcomes

  1. Pain inventory

    Time frame: 3 months

    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.

  2. Hand grip strength

    Time frame: 3 months

    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. Healthy related quality of life

    Time frame: 3 months

    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.

  4. Functional capacity

    Time frame: 3 months

    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.

  5. Disease activity

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Federal University of Espirito Santo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
May 16, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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