Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis

NCT04481984 | Completed

• 1 other identifier: Cukurova Uni. Neslihan G.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of the skin and internal organs. Hand involvement is one of the most observed musculoskeletal involvements in patients with SSc, which can impact on general health, quality of life, and psychological status. Hand exercise programs can help patients to improve not only hand function but also general health status; nevertheless, further randomized control trials (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the effectiveness of home-based, self-administered exercise program for hands in patients with SSc and demonstrate the improvements in general health status.

Conditions

Systemic Sclerosis; Scleroderma; Hand Rheumatism; Rehabilitation

Keywords

Systemic sclerosis; Scleroderma; Hand; Rehabilitation; Exercise therapy; Self-management

Outcome Measures

Primary Outcomes (1)

• Handgrip strength

  Handgrip strength was measured by hydraulic hand dynamometer (JAMAR®,USA) according to the standard protocol, which calculates the average of three consecutive measurements of the dominant hand. The measurements were recorded as kilograms (kg).

  Before treatment to 8 weeks

Secondary Outcomes (1)

• Duruoz Hand Index

  Before treatment to 8 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

The training including isometric and stretching hand exercise was applied once by a physiatrist. A hand exercise ball was used for isometric exercise. Patients performed both stretching exercises and isometric exercises according to the training and printed materials. The home-based exercise program was implemented 7 days per week during an 8-week period. In addition, patients received recommendations such as avoiding cold exposure and trauma.

Other: Home-based Hand exercise

Control group

OTHER

Patients received care advice including avoiding cold exposure and trauma.

Other: Care advice

Interventions

Home-based Hand exercise OTHER

Isometric exercise; patients squeezed a hand exercise ball for 60 seconds. This exercise repeated 15-times/3 set per day. Stretching exercises; self-administered stretching exercises were as follows; i) forearm supination and pronation, ii) wrist flexion and extension, iii) finger flexion, extension, and abduction iv) thumb flexion, extension, and abduction. These exercises repeated 10-times/2 set per day.

Also known as: Rehabilitation

Exercise group

Care advice OTHER

Patients received care advice including avoiding cold exposure and trauma.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female patients with Systemic sclerosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Female systemic sclerosis patients who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis

You may not qualify if:

• Patients with neurological disorders,
• Arthritis,
• Myositis,
• Amputation of fingers,
• Serious contracture resisting hand grip
• History of undergoing hand surgery

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Location

Related Publications (9)

• Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.

  PMID: 29198478 BACKGROUND

• Stefanantoni K, Sciarra I, Iannace N, Vasile M, Caucci M, Sili Scavalli A, Massimiani MP, Passi L, Maset L, Riccieri V. Occupational therapy integrated with a self-administered stretching program on systemic sclerosis patients with hand involvement. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):157-161. Epub 2016 Apr 14.

  PMID: 27087678 BACKGROUND

• Mugii N, Hasegawa M, Matsushita T, Kondo M, Orito H, Yanaba K, Komura K, Hayakawa I, Hamaguchi Y, Ikuta M, Tachino K, Fujimoto M, Takehara K, Sato S. The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. J Rheumatol. 2006 Aug;33(8):1586-92.

  PMID: 16881115 BACKGROUND

• Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859.

  PMID: 24812476 BACKGROUND

• Liem SIE, Vliet Vlieland TPM, Schoones JW, de Vries-Bouwstra JK. The effect and safety of exercise therapy in patients with systemic sclerosis: a systematic review. Rheumatol Adv Pract. 2019 Dec 9;3(2):rkz044. doi: 10.1093/rap/rkz044. eCollection 2019.

  PMID: 31858074 BACKGROUND

• Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.

  PMID: 27696703 BACKGROUND

• Piga M, Tradori I, Pani D, Barabino G, Dessi A, Raffo L, Mathieu A. Telemedicine applied to kinesiotherapy for hand dysfunction in patients with systemic sclerosis and rheumatoid arthritis: recovery of movement and telemonitoring technology. J Rheumatol. 2014 Jul;41(7):1324-33. doi: 10.3899/jrheum.130912. Epub 2014 Jun 1.

  PMID: 24882841 BACKGROUND

• Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):909-17. doi: 10.1002/acr.20448.

  PMID: 21312348 BACKGROUND

• Gokcen N, Badak SO, Sarpel T, Sertdemir Y, Erken E. The Efficacy of a Home-Based, Self-Administered Hand Exercise Program for Patients With Systemic Sclerosis: A Randomized Controlled, Evaluator-Blind, Clinical Trial. J Clin Rheumatol. 2022 Mar 1;28(2):e422-e429. doi: 10.1097/RHU.0000000000001752.

  PMID: 34030163 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled, Single-blind, Clinical Study

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 22, 2020
• Study Start: July 15, 2016
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Up to 6 months
• Access Criteria: Researchers who would like to access to individual participant data will be reviewed and approved by the principal investigator.

Locations

TU (1)