The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis

Gazi University

Status: Unknown

Conditions: Systemic Sclerosis

Treatments: Other: Exercise training group; Other: Control training group

Study type: Interventional

Funder types: Other

Identifiers

NCT05078749

208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Exercise training group

Active Comparator group

Description:

Continuous progressive exercise training will be applied to the treatment group. The exercises will be performed every day, twice a day, for an average of 10 minutes/session, for eight weeks. Exercise training will be updated regularly at two-week intervals. A different and progressive new exercise will be sent to the patients as a Youtube link. The patients will be interviewed by video every week.

Treatment:

Other: Exercise training group

Control training group

Sham Comparator group

Description:

The control group will be followed up as a home program by explaining the exercises and giving a brochure. They will be asked to do the exercises regularly for 7 days/week, 2 sessions/day, for eight weeks. Patients in the control group will be followed up by phone once a week.

Treatment:

Other: Control training group