Exercise With Scleroderma Functional Outcomes

Trakya University

Status: Completed

Conditions: Hand Rheumatism; Scleroderma, Limited; Scleroderma, Systemic; Scleroderma, Diffuse; Mouth Movement Impaired

Treatments: Other: Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06425653

20-9T/25

Details and patient eligibility

About

The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life).

Full description

Systemic sclerosis (scleroderma) is a significant, rare autoimmune connective tissue disease characterized by autoantibodies, fibrosis of the skin and internal organs, microvascular injury and vascular damage due to endothelial cell activation (Sepulveda et al., 2019; Rosendahl et al., 2022). The term "scleroderma" is derived from two Greek words "sklero" and "derma" meaning hard skin (Bielacka et al., 2017; Singh et al., 2019).

The global prevalence of scleroderma is estimated to be between 0.3 and 40 per 100,000 population (Alhendi et al., 2020; Benz et al., 2021; Sierakowska et al., 2019). The occurrence of systemic sclerosis in women is three to five times and in some literature up to eight times higher than in men. The disease incidence peaks between the ages of 30 and 65 (Sierakowska et al., 2019; Hughes et al., 2020; Alhendi et al., 2020).

Impairment of hand functions is one of the most significant disabilities in patients with scleroderma and is commonly observed (Gregory et al., 2019; Mugii et al., 2019). The skin of the hand thickens with manifestations including fingertip ulcers, swelling of the fingers, raynaud's phenomenon and subcutaneous calcium deposition (Abreu et al., 2023). Deformities such as loss of flexion in the metacarpophalangeal joints, loss of extension in the proximal and distal interphalangeal joints, loss of abduction, flexion of the thumb and wrist movement can occur, leading to contractures and severe impairment of hand functions (Bongi & Rosso, 2016; Vannajak et al., 2014).

Besides hand function impairment, another significant issue in scleroderma is the fibrotic involvement of the connective tissue of the face and mouth. Patients tend to lose facial expression. Sclerosis of the skin around the lips and mouth area causes a reduction in mouth opening (microstomia) and width (microcheilia) in 43% to 80% of cases (Puzio et al., 2019; Uras et al., 2019).

Rehabilitation strategies which play a crucial role in the management of scleroderma, include psychoeducational interventions, exercise therapy, application of physical methods, assistive devices and orthoses; joint protection and energy conservation approaches, dietary interventions and comprehensive multidisciplinary team care programs (Schouffoer et al., 2011). Among these interventions daily hand exercises are specifically mentioned to improve hand movement and function, and also mouth and facial exercises positively affect mouth opening function (Gregory et al., 2019). Hand rehabilitation enhances hand movement, functionality and strength, as well as participation in daily life activities such as self-care, housework, work and recreational activities, thereby improving quality of life (Bongi & Rosso, 2016). Exercises that stretch the mouth and increase mouth opening are reported to prevent the progression of microstomia and reduce limitations in mouth opening (Puzio et al., 2019; Yuen et al., 2012). Some approaches and techniques involving active exercises for managing microstomia are suggested, indicating success with the performance of mandibular movements (Puzio et al., 2019).

Programs that include hand and oral rehabilitation interventions are needed to prevent hand deformities and oral dysfunctions, ensure positive body perception, provide coping strategies and maintain quality of life (Schouffoer et al., 2011; Vannajak et al., 2014). However, individuals with a rare disease such as scleroderma face many challenges, including lack of knowledge about the disease, difficulties in accurate diagnosis and limited treatment and support options. Professional support services that are usually provided to individuals with more common diseases are not available for scleroderma patients (Delisle et al., 2019).

Scleroderma is a chronic disease that affects multiple systems and can present numerous symptoms and complications, impacting individuals physically, psychologically and socially. Therefore, the care of patients with scleroderma requires an interdisciplinary holistic health approach that encompasses both physical and emotional support. The rarity of scleroderma, the fact that many patients live far from physical therapy and rehabilitation clinics or the necessity of continuous participation in a program necessitates the implementation of nurse-led home programs (Murphy et al., 2018).

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The inclusion criteria were being aged between 18 to 70 years, having no communication problems, being able to speak Turkish and agreeing to participate in the study.

Exclusion criteria

• . The exclusion criteria were not having the ability to regularly perform hand and mouth exercises, having undergone hand surgery in the last six months, having open wounds or contractures on the hand, having hand and mouth functional disorders due to reasons other than scleroderma, having no teeth, having all upper and lower teeth as dentures and being included in a rehabilitation program in the last three months.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Exercise Program

Experimental group

Description:

In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization

Treatment:

Other: Exercise Program

Standart Protocol

No Intervention group

Description:

The standard protocol included routine care and treatment practices conducted by the same physician at the same institution.