Systemic SclerosisNCT05078749
The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis
A study testing Exercise training group in people with Systemic Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Exercise training group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Deran OSKAY, Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Çankaya, Ankara
Fulden SARİ, doktorate, fuldensari@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Exercise training group, Control training group
- Keywords
- systemic sclerosis, scleroderma, telerehabilitation, exercise
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training groupOther
A regular advanced exercise program will be given and followed.
Control training groupOther
Basic exercises will be given at the beginning and will do the same exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Active comparator | 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. Receives: Other: Exercise training group |
| Control training group | Sham comparator | 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. Receives: Other: Control training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First day
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.
Measured: First day
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.
Measured: First day
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'.
Measured: First day
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.
Measured: First day
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.
Measured: First day
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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulden Sarı, Gazi University
- Investigators
- Deran OSKAY, Prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078749
- Sponsor's protocol ID
- 208
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05078749
- Acronym / sponsor ID
- 208
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, scleroderma, telerehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training group | Active comparator | Other: Exercise training groupContinuous 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. |
| Control training group | Sham comparator | Other: Control training groupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training groupA regular advanced exercise program will be given and followed. | Other | Exercise training group |
| Control training groupBasic exercises will be given at the beginning and will do the same exercises | Other | Control training group |
Primary outcome
Numerical Evaluation Scale-Pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Related trials for Systemic Sclerosis
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deran OSKAY, Prof contact
Deran OSKAY, Prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training group in people with Systemic Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulden SARİ, doctorate (+90 5069654352, fuldensari@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Evaluation Scale-Pain (time frame: First day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.