Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425653
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-10
Brief Title:
Exercise With Scleroderma Functional Outcomes
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 03 and 40 per 100000 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 raynauds 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
The global prevalence of scleroderma is estimated to be between 03 and 40 per 100000 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 raynauds 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None