SARAH Exercise Program in Patients With Rheumatoid Arthritis

July 10, 2024 updated by: Deniz Bayraktar, Izmir Katip Celebi University

Investigating the Effects of SARAH Exercise Program on Proprioception and Hand Functions in Patients With Rheumatoid Arthritis

The aim of this study is to investigate the effectiveness of the SARAH home exercise program to be applied for 12 weeks on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Finger/hand/wrist joints can be affected in the early period in patients with RA, and as the disease progresses, it can significantly limit the patient's functionality. Damage to articular and periarticular structures seen in inflammatory arthritis may affect the sense of proprioception by destroying mechanoreceptors located in these areas. Hand functions may worsen as a result of the worsening of the sense of proprioception, which can be defined as being aware of body parts.

SARAH (Strengthening and Stretching for Rheumatoid Arthritis of the Hand) home exercise program, which is a widely preferred approach in the case of hand involvement in patients with rheumatoid arthritis (RA), includes exercises to increase hand-wrist strength and mobility. Although the effectiveness of this program on pain, muscle strength, and range of motion has been demonstrated in large patient groups, its effect on proprioception and hand functions, which may be caused by inflammatory arthritis, has not been studied. Therefore, this study aims to investigate the effectiveness of the SARAH home exercise program on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. RA diagnosis according to 2010 ACR/EULAR RA criteria
  2. Being between the ages of 18-65
  3. Being able to follow Turkish instructions
  4. Volunteering to participate in the study

Exclusion Criteria:

  1. Being in an acute disease exacerbation period
  2. Ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months
  3. History of steroid injection, surgery, or trauma to the upper extremity in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
The SARAH exercise program will be delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) on a weekly basis.
Other: Exercise
Participants will be asked to practice home exercises every day of the week for 12 weeks. The SARAH exercise program consists of 7 mobility and 4 strengthening exercises. Progress will be made by increasing the repetitions and duration of the exercises every week.
No Intervention: Control
Patients in the control group will not receive any exercise intervention. They will only maintain their routine medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wrist Joint Position Sense
Time Frame: At baseline and twelve weeks later
Wrist joint position sense will be evaluated with joint position sense goniometry. Joint position sense is measured by the ability to actively repeat a predetermined target angle. During the measurement, the wrist of the participant will passively be brought to the target angle and be kept in this position for three seconds. The participant will be asked to keep this position in his/her memory, then the wrist will passively be brought to the starting position. Then, the participant will be requested to bring her/his hand actively to these predetermined position. Wrist movements will be determined as three repetitive measurements for flexion, extension, radial deviation, and ulnar deviation directions.
At baseline and twelve weeks later
Change in Hand Performance
Time Frame: At baseline and twelve weeks later
Hand performance will be evaluated Nine-Hole Peg Test.
At baseline and twelve weeks later
Change in Grip Strength
Time Frame: At baseline and twelve weeks later
Hand grip strength will be evaluated with a hand-dynamometer.
At baseline and twelve weeks later
Change in Pinch Strength
Time Frame: At baseline and twelve weeks later
Pinch strength will be evaluated by using a pinchmeter.
At baseline and twelve weeks later
Change in Self-reported Hand Functions
Time Frame: At baseline and twelve weeks later
Duruoz Hand Index and The Measures of Activity Performance of the Hand Questionnaire will be used for subjective assessment of hand functions. Higher scores in both questionnaires reflect poorer hand functions.
At baseline and twelve weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: At baseline and twelve weeks later
Numeric rating scale (NRS) will be used for pain assessment. NRS is scored between 0-10 and, higher scores indicate higher level of pain.
At baseline and twelve weeks later
Change in Morning Stiffness
Time Frame: At baseline and twelve weeks later
Morning stiffness related to the hand/wrist of the patients will be questioned by using Numeric Rating Scale (0-10) in terms of duration and severity. Higher scores indicate worse morning stiffness.
At baseline and twelve weeks later
Change in Disease Activity
Time Frame: At baseline and twelve weeks later
Disease Activity 28 C-Reactive Protein (DAS28-CRP) will be used to evaluate disease activity.
At baseline and twelve weeks later
Change in General Functioning
Time Frame: At baseline and twelve weeks later
Health Assessments Questionnaire-Disability Index, which is a self-report tool and has 20 items, will be used to evaluate the general functioning. All items are scored between 0 and 3. All scores are summed and divided by 20 to obtain a total score (0-3). Higher scores indicate a worse functional status.
At baseline and twelve weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Principal Investigator: Deniz Bayraktar, PT, PhD, Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

June 26, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 4, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARAHRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable requests.

IPD Sharing Time Frame

Data will be available after completing the study and will be available for 20 years.

IPD Sharing Access Criteria

Data will be shared for only academic purposes (for conducting a meta-analysis or a systematic review)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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