Clinical trial NCT05375422: Effects of SARAH Protocol in Women With Rheumatoid Arthritis
Official title: Effects of the Strengthening and Stretching Protocol for Rheumatoid Arthritis in the Hands (SARAH) on Hand Function in Women With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: exercise
hand
physical therapy
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hand function
timeFrame: 3 months
Secondary outcomes:
measure: Pain inventory
timeFrame: 3 months
measure: Hand grip strength
timeFrame: 3 months
measure: Healthy related quality of life
timeFrame: 3 months
measure: Functional capacity
timeFrame: 3 months
measure: Disease activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: Samira Tatiyama Miyamoto, PhD
state: ES
Study officials:
References: