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Effects of SARAH Protocol in Women With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
SARAH
Educational intervention
Sponsored by
Federal University of Espirito Santo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring exercise, hand, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Samira Tatiyama Miyamoto, PhDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SARAH group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain inventory
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.
Hand grip strength
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.
Healthy related quality of life
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.
Functional capacity
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.
Disease activity
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.

Full Information

First Posted
May 11, 2022
Last Updated
May 11, 2022
Sponsor
Federal University of Espirito Santo
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1. Study Identification

Unique Protocol Identification Number
NCT05375422
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
May 7, 2022 (Actual)
Study Completion Date
February 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
exercise, hand, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SARAH group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SARAH
Intervention Description
Set of exercises with components of muscle strengthening, range of motion gain and home exercises.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
Information related to joint protection, use of splints, assistive devices and other general advice, as needed.
Primary Outcome Measure Information:
Title
Hand function
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain inventory
Description
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.
Time Frame
3 months
Title
Hand grip strength
Description
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.
Time Frame
3 months
Title
Healthy related quality of life
Description
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.
Time Frame
3 months
Title
Functional capacity
Description
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.
Time Frame
3 months
Title
Disease activity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women over 18 years old
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samira T Miyamoto, PhD
Phone
+55 27 997606447
Email
sa.miyamoto@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ludmila Forechi, PhD
Phone
+55 21 998132300
Email
ludimilaforechi@yahoo.com.br
Facility Information:
Facility Name
Samira Tatiyama Miyamoto, PhD
City
Vitória
State/Province
ES
ZIP/Postal Code
29050-780
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samira T Miyamoto, PhD
Phone
+55 27 997606447
Email
sa.miyamoto@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of SARAH Protocol in Women With Rheumatoid Arthritis

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