SARAH Exercise Program in Patients With Rheumatoid Arthritis

NCT05727488 | Completed

• 1 other identifier: SARAHRA
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Hand; Proprioception; Exercise

Outcome Measures

Primary Outcomes (5)

• 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

• Change in Hand Performance

  Hand performance will be evaluated Nine-Hole Peg Test.

  At baseline and twelve weeks later

• Change in Grip Strength

  Hand grip strength will be evaluated with a hand-dynamometer.

  At baseline and twelve weeks later

• Change in Pinch Strength

  Pinch strength will be evaluated by using a pinchmeter.

  At baseline and twelve weeks later

• 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 Outcomes (4)

• Change in Pain

  At baseline and twelve weeks later

• Change in Morning Stiffness

  At baseline and twelve weeks later

• Change in Disease Activity

  At baseline and twelve weeks later

• Change in General Functioning

  At baseline and twelve weeks later

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in the control group will not receive any exercise intervention. They will only maintain their routine medical treatment.

Interventions

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 33609792 BACKGROUND

• 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). 2022 May;95:105640. doi: 10.1016/j.clinbiomech.2022.105640. Epub 2022 Apr 4.

  PMID: 35405540 BACKGROUND

• 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.

  PMID: 17612988 BACKGROUND

• 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.

  PMID: 27156434 BACKGROUND

• 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.

  PMID: 30063798 BACKGROUND

• 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.

  PMID: 22507362 BACKGROUND

• 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.

  PMID: 25308290 BACKGROUND

• 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.

  PMID: 29731662 BACKGROUND

• 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.

  PMID: 27870649 BACKGROUND

• 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.

  PMID: 8823687 BACKGROUND

• 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.

  PMID: 22020457 BACKGROUND

• 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.

  PMID: 18796752 BACKGROUND

• 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.

  PMID: 14734079 BACKGROUND

• 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.

  PMID: 9735592 BACKGROUND

• 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.

  PMID: 33858982 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Deniz Bayraktar, PT, PhD

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 14, 2023
• Study Start: November 16, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after completing the study and will be available for 20 years.
• Access Criteria: Data will be shared for only academic purposes (for conducting a meta-analysis or a systematic review)

Locations

TU (1)