SARAH Exercise Program in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05727488
• Other study ID #: SARAHRA
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: December 2023
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018. — View Citation

Bearne LM, Coomer AF, Hurley MV. Upper limb sensorimotor function and functional performance in patients with rheumatoid arthritis. Disabil Rehabil. 2007 Jul 15;29(13):1035-9. doi: 10.1080/09638280600929128. — View Citation

Duruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72. — View Citation

Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08. — View Citation

Figus FA, Piga M, Azzolin I, McConnell R, Iagnocco A. Rheumatoid arthritis: Extra-articular manifestations and comorbidities. Autoimmun Rev. 2021 Apr;20(4):102776. doi: 10.1016/j.autrev.2021.102776. Epub 2021 Feb 17. — View Citation

Haidar SG, Kumar D, Bassi RS, Deshmukh SC. Average versus maximum grip strength: which is more consistent? J Hand Surg Br. 2004 Feb;29(1):82-4. doi: 10.1016/j.jhsb.2003.09.012. — View Citation

Halpern CA, Fernandez JE. The effect of wrist and arm postures on peak pinch strength. J Hum Ergol (Tokyo). 1996 Dec;25(2):115-30. — View Citation

Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215. — View Citation

Heine PJ, Williams MA, Williamson E, Bridle C, Adams J, O'Brien A, Evans D, Lamb SE; SARAH Team. Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial. Physiotherapy. 2012 Jun;98(2):121-30. doi: 10.1016/j.physio.2011.03.001. — View Citation

Jensen Hansen IM, Asmussen Andreasen R, van Bui Hansen MN, Emamifar A. The Reliability of Disease Activity Score in 28 Joints-C-Reactive Protein Might Be Overestimated in a Subgroup of Rheumatoid Arthritis Patients, When the Score Is Solely Based on Subjective Parameters: A Cross-sectional, Exploratory Study. J Clin Rheumatol. 2017 Mar;23(2):102-106. doi: 10.1097/RHU.0000000000000469. — View Citation

Kopruluoglu M, Naz I, Solmaz D, Akar S. Hand functions and joint position sense in patients with psoriatic arthritis- a comparison with rheumatoid arthritis and healthy controls. Clin Biomech (Bristol, Avon). 2022 May;95:105640. doi: 10.1016/j.clinbiomech.2022.105640. Epub 2022 Apr 4. — View Citation

Lamb SE, Williamson EM, Heine PJ, Adams J, Dosanjh S, Dritsaki M, Glover MJ, Lord J, McConkey C, Nichols V, Rahman A, Underwood M, Williams MA; Strengthening and Stretching for Rheumatoid Arthritis of the Hand Trial (SARAH) Trial Team. Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial. Lancet. 2015 Jan 31;385(9966):421-9. doi: 10.1016/S0140-6736(14)60998-3. Epub 2014 Oct 9. — View Citation

Leung YY, Tillett W, Hojgaard P, Orbai AM, Holland R, Mathew AJ, Goel N, Chau J, Lindsay CA, Ogdie A, Coates LC, Christensen R, Mease PJ, Strand V, Gladman DD. Test-retest Reliability for HAQ-DI and SF-36 PF for the Measurement of Physical Function in Psoriatic Arthritis. J Rheumatol. 2021 Oct;48(10):1547-1551. doi: 10.3899/jrheum.210175. Epub 2021 Apr 15. — View Citation

Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016 Oct 22;388(10055):2023-2038. doi: 10.1016/S0140-6736(16)30173-8. Epub 2016 May 3. Erratum In: Lancet. 2016 Oct 22;388(10055):1984. — View Citation

Williams MA, Srikesavan C, Heine PJ, Bruce J, Brosseau L, Hoxey-Thomas N, Lamb SE. Exercise for rheumatoid arthritis of the hand. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD003832. doi: 10.1002/14651858.CD003832.pub3. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wrist Joint Position Sense	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
Primary	Change in Hand Performance	Hand performance will be evaluated Nine-Hole Peg Test.	At baseline and twelve weeks later
Primary	Change in Grip Strength	Hand grip strength will be evaluated with a hand-dynamometer.	At baseline and twelve weeks later
Primary	Change in Pinch Strength	Pinch strength will be evaluated by using a pinchmeter.	At baseline and twelve weeks later
Primary	Change in Self-reported Hand Functions	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	Change in Pain	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
Secondary	Change in Morning Stiffness	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
Secondary	Change in Disease Activity	Disease Activity 28 C-Reactive Protein (DAS28-CRP) will be used to evaluate disease activity.	At baseline and twelve weeks later
Secondary	Change in General Functioning	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