Clinical trial NCT05078749: The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis
Official title: The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
scleroderma
telerehabilitation
exercise
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase. In addition to medical treatment, rehabilitation programs for the patient are an important part of treatment to eliminate or reduce these symptoms and their consequences.

Many problems such as time and resource constraints, transportation problems prevent access and compliance with the rehabilitation program. Also; For the coronavirus disease 2019 (COVID-19) epidemic that emerged in Wuhan, China in 2019, many countries have implemented many practices such as social distance, mandatory quarantine and transportation restrictions in order to better control the spread of the virus. Many people with SSc are at risk of serious complications from COVID-19 if infected due to lung involvement (\>40% have interstitial lung disease) and widespread use of immunosuppressant drugs. Most countries have recommended that people with medical conditions such as SSc undergo strict isolation during the COVID-19 pandemic. As a result, patients' access to the rehabilitation program became more difficult in this process. In addition, social isolation due to the COVID-19 outbreak may increase physical inactivity and cause complications that may develop accordingly.

When the literature was examined, no studies were found showing the effect of telerehabilitation program on anxiety depression, physical activity, sleep, fatigue and quality of life in patients with SSc.

Detailed description: According to sample size calculation 26 patients scheduled for systemic sclerosis will be included. Patients planned for systemic sclerosis will be evaluated twice at the beginning and at the end of the 8th week. The study was planned as a prospective randomized controlled study. Patients will be randomized using a computer program and divided into two groups as telerehabilitation treatment and home exercise group. For the telerehabilitation group, a progressive exercise program video link will be sent over the internet every 2 weeks. The exercise brochure will be explained and sent to the patient group followed up with the home program only at the beginning of the program.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65
* Being literate
* Patients who received standard medical treatment and whose general condition has been stable for the last 6 months
* Having minimum smartphone or computer usage knowledge or having an acquaintance who knows this information and can help with this
* Having a computer and active internet connection at home
* Disease duration between 1 and 10 years
* Agree to participate in the study

Exclusion Criteria:

* Patients who cannot cooperate with the assessment
* Those who have orthopedic problems or neurological diseases that prevent them from doing the exercises
* Those who received treatment in a physiotherapy and rehabilitation program before
* Patients with another inflammatory disease
* Female patients who are pregnant
* Patients who have had COVID-19
* Those with a diagnosis of pulmonary arterial hypertension (PAH)
* Exercise is contraindicated for those with heart disease.

Primary outcomes:
measure: Numerical Evaluation Scale-Pain
timeFrame: First day
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: First day
measure: Multidimensional Assessment of Fatigue Scale
timeFrame: First day
measure: International Physical Activity Questionnaire-short form
timeFrame: First day
measure: Pittsburgh sleep quality index
timeFrame: First day
measure: Hospital Anxiety and Depression Scale
timeFrame: First day
measure: Nottingham Health Profile
timeFrame: First day
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Gazi University
state: Ankara
Study officials:
affiliation: Gazi University
name: Deran OSKAY, Prof
role: STUDY_DIRECTOR
References: