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

Sponsor

Gazi University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05078749

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Other: Exercise training group Other: Control training group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exercise training group 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.	Other: Exercise training group A regular advanced exercise program will be given and followed.
Sham Comparator: Control training group 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.	Other: Control training group Basic exercises will be given at the beginning and will do the same exercises

Arm

Intervention/Treatment

Active Comparator: Exercise training group

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.

Other: Exercise training group

A regular advanced exercise program will be given and followed.

Sham Comparator: Control training group

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.

Other: Control training group

Basic exercises will be given at the beginning and will do the same exercises

Outcome Measures

Primary Outcome Measures

Numerical Evaluation Scale-Pain [First day]
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
Modified Medical Research Council Dyspnea Scale [First day]
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.
Multidimensional Assessment of Fatigue Scale [First day]
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.
International Physical Activity Questionnaire-short form [First day]
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'.
Pittsburgh sleep quality index [First day]
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.
Hospital Anxiety and Depression Scale [First day]
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.
Nottingham Health Profile [First day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.