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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis: a Randomized Controlled, Single-blind, Clinical Trial

Conditions
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Systemic Sclerosis, Scleroderma, Hand Rheumatism, Rehabilitation

Intervention / Treatment
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* Other: Home-based Hand exercise
* Other: Care advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Female systemic sclerosis patients who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis Exclusion Criteria: Patients with neurological disorders, Arthritis, Myositis, Amputation of fingers, Serious contracture resisting hand grip History of undergoing hand surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled, Single-blind, Clinical Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>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<br>* 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.<br>* Other names: Rehabilitation;|
| Other: Control group<br>Patients received care advice including avoiding cold exposure and trauma. | Other: Care advice<br>* Patients received care advice including avoiding cold exposure and trauma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duruoz Hand Index | Duruoz Hand Index (DHI) is the 18-item questionnaire assessing hand skill in the kitchen, during dressing, while performing personal hygiene, while performing office tasks, and other general performances. Each item is rated from 0 (no difficulty) to 5 (impossible to do). The sum of the scores varies between 0 and 90. Higher scores indicate the impaired hand function. | Before treatment to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic sclerosis, Scleroderma, Hand, Rehabilitation, Exercise therapy, Self-management