Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis
Condition: Systemic Sclerosis; Scleroderma; Hand Rheumatism; Rehabilitation
MeSH terms: Rheumatic Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

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.
    

Detailed description: 
      The current study was designed as a single-blind, prospective, randomized controlled,
      comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient
      clinic of a university hospital, between July 2016-June 2019. Female patients with SSc who
      fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis were included in
      the study. Patients with neurological disorders, arthritis, myositis, amputation of fingers,
      serious contracture resisting handgrip, and history of undergoing hand surgery were excluded
      from the study. Patients were enrolled in the study after they signed the written informed
      consent. Following the assessment of patients in terms of eligibility, patients were
      randomized into an exercise and a control group. The computerized block randomization method
      was used to randomize subjects into groups. Both groups were informed about systemic
      sclerosis and they received the printed materials that include recommendations such as
      avoiding cold and trauma. The treatment group participated in a single hand exercise training
      (isometric hand exercise and self-administered stretching) applied by a physiatrist. They
      additionally received the printable instructions for exercises. Compliance was assessed by a
      checklist, which included all information on how to exercise and how many times to do them.
      The investigators aimed to investigate the impact of hand exercise program on hand function
      and demonstrate its influence on health status, quality of life, and psychological status of
      patients with SSc.
    

Intervention name(s): Home-based Hand exercise; Care advice
Intervention type(s): Other; Other
Intervention description(s): 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.; Patients received care advice including avoiding cold exposure and trauma.
Other intervention name(s): Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled, Single-blind, Clinical Study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic sclerosis; Scleroderma; Hand; Rehabilitation; Exercise therapy; Self-management