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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078749
• Other study ID #: 208
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2021
• Source: Gazi University
• Contact: Fulden SARI, doctorate
• Phone: +90 5069654352
• Email: fuldensari[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Exercise training group
A regular advanced exercise program will be given and followed.
• Control training group
Basic exercises will be given at the beginning and will do the same exercises

Locations

Country	Name	City	State
Turkey	Gazi University	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Evaluation Scale-Pain	The Numeric Rating Scale (NRS) was used to determine the pain level of the patients at rest, activity and at night. Patients are asked to mark the numbers between 0 and 10 at the time of assessment, in terms of rest, activity and night pain. 10 score describe severe pain while 0 score is no pain	First day
Primary	Modified Medical Research Council Dyspnea Scale	Assessment of dyspnea was assessed with the Modified Medical Research Council (MMRC) dyspnea scale. The MMRC is a category scale consisting of 5 statements about dyspnea, scored between 0-4. As the score obtained by the patient increases, the complaint of dyspnea increases.	First day
Primary	Multidimensional Assessment of Fatigue Scale	Fatigue assessment will be evaluated with the Turkish Version of the Multidimensional Fatigue Scale (MAF-T). The MAF-T is a 4-dimensional questionnaire that assesses the degree and severity of fatigue, the amount, duration, and type of distress it causes. According to their answers, the patients score at least 1 (no fatigue) and 50 (severe fatigue) points from the test.	First day
Primary	International Physical Activity Questionnaire-short form	Physical activity level was evaluated with Turkish valid and reliable International Physical Activity (IPAQ) questionnaire. The questionnaire consisting of 7 questions gives information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered as a separate question. A score is obtained in total score metabolic equivalent (MET)-minutes. According to the result, physical activity level is classified as 'inactive', 'minimally active' and 'very active'.	First day
Primary	Pittsburgh sleep quality index	Sleep will be assessed by the Pittsburgh sleep quality index (PUKI). The questionnaire consists of a total of 24 questions; The first 19 questions are answered by the person, and the last 5 questions are answered by the person's family or roommate. The total score of the questionnaire varies between 0-21. The higher the PUKI score, the worse the sleep quality is. A total PUKI score of < 5 indicates 'good' sleep quality, and a total PUKI score of = 5 indicates 'poor' sleep quality.	First day
Primary	Hospital Anxiety and Depression Scale	A valid and reliable Turkish Hospital Anxiety and Depression Scale (HADS) was used to determine the anxiety and depression levels of the patients. In the questionnaire consisting of a total of 14 questions, odd-numbered questions assess anxiety and even-numbered questions assess depression. It has two subgroups, anxiety (HADS-A) and depression (HADS-D). The lowest score that patients can get from both subgroups is 0, and the highest score is 21.	First day
Primary	Nottingham Health Profile	Quality of life will be assessed with the Turkish version of the Notthingham Health Profile (NSP) scale. NSP evaluates the physical, social and emotional health problems perceived by the patient at that moment in 2 parts. Each subgroup is scored between 0-100 in itself. The total score of the NSP questionnaire is between 0-600. A high score indicates poor quality of life.	First day