SARAH Exercise Program in Patients With Rheumatoid Arthritis

NCT ID: NCT05727488

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-16

Study Completion Date

2024-06-26

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Deniz Bayraktar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Bayraktar, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Izmir Katip Celebi University

Locations

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Izmir Katip Celebi University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33609792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35405540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17612988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27156434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30063798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22507362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25308290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29731662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27870649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8823687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22020457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18796752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14734079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9735592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33858982 (View on PubMed)

Other Identifiers

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SARAHRA

Identifier Type: -

Identifier Source: org_study_id

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