SARAH Exercise Program in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Exercise

• Registration Number: NCT05727488
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-04
• Study First Posted: 2023-02-14
• Study Start: 2023-11-16
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in Hand Performance	At baseline and twelve weeks later	Hand performance will be evaluated Nine-Hole Peg Test.
Change in Grip Strength	At baseline and twelve weeks later	Hand grip strength will be evaluated with a hand-dynamometer.
Change in Self-reported Hand Functions	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.
Change in Wrist Joint Position Sense	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.
Change in Pinch Strength	At baseline and twelve weeks later	Pinch strength will be evaluated by using a pinchmeter.

Secondary Outcome Measures

Name	Time	Method
Change in Pain	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.
Change in General Functioning	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.
Change in Morning Stiffness	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.
Change in Disease Activity	At baseline and twelve weeks later	Disease Activity 28 C-Reactive Protein (DAS28-CRP) will be used to evaluate disease activity.

Trial Locations

Locations (1)

Izmir Katip Celebi University; 🇹🇷 İzmir, Turkey