TelerehabilitationNCT05493384
Telerehabilitation in Rheumatic Diseases
A study testing Telerehabilitation Group in people with Telerehabilitation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Telerehabilitation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 20 Nov 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
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Who cannot join
- Being pregnant
- Diagnosed with malignancy
- Had changes of medical treatment in the last 3 months
- Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
- Had regular exercise habit (minimally three days in a week)
- Had cardiac symphtoms according to New York Heart Association
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23119
Songul B Yentur, +90 424 2370000, songulbaglan23@hotmail.com
About this study
Official title: Telerehabilitation in Rheumatic Diseases During the Process of COVID-19 Pandemic
Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.
Read the detailed description
Telerehabilitation (TR) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians. It provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies. COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. Physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.The importance and requirement for TR were observed better during the COVID-19 pandemic. Therefore, aim of this study was to investigate the effects of TR on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.
- Conditions
- Telerehabilitation
- Being tested
- Telerehabilitation Group
- Keywords
- Telerehabilitation, Rheumatic diseases, COVID-19
- Medical subject headings
- Rheumatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation GroupOther
The program will include stretching, strengthening, breathing, posture, proprioceptive, relaxation exercises and segmental extremity movements. Each exercise will be performed 10 times in a session for the first 4 weeks and 15 times for the last 4 weeks. Exercises will be performed progressively on the patients.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | The Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom. Receives: Other: Telerehabilitation Group |
| No Intervention group | No intervention | No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7
Measured: 2 minutes
Hospital Anxiety and Depression Scale
It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety. Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression
Measured: 2 minutes
Secondary outcomes (2)
Pittsburg Sleep Quality Index
It assesses sleep quality and disturbances over a month's time interval and consists of 19 self-rated items and five questions.It contains 7 subscales and total score is sum of these subscales. Each item is scored 0-3 and total score is changed between 0 to 21 which high scores indicate worse sleep quality.
Measured: 3 minutes
Health Assessment Questionnaire
The questions of Health Assessment Questionnaire are about dressing and grooming, arising, eating, walking, hygiene, reach, grip and activity. The questionnaire consists of 20 questions and each question is scored from 0 to 3. Higher scores indicate worse quality of life
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start25 Jul 2022
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Baglan Yentur, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493384
- Sponsor's protocol ID
- 7099
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation in Rheumatic Diseases During the Process of COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05493384
- Acronym / sponsor ID
- 7099
- Conditions
- Telerehabilitation
- Keywords
- Telerehabilitation, Rheumatic diseases, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 9 Aug 2022 (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.
Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.
Detailed description
Telerehabilitation (TR) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians. It provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies. COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. Physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.The importance and requirement for TR were observed better during the COVID-19 pandemic. Therefore, aim of this study was to investigate the effects of TR on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Telerehabilitation GroupThe Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom. |
| No Intervention group | No intervention | –No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Key exclusion criteria (6 listed)
- Being pregnant
- Diagnosed with malignancy
- Had changes of medical treatment in the last 3 months
- Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
- Had regular exercise habit (minimally three days in a week)
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 |
|---|---|---|
| Telerehabilitation GroupThe program will include stretching, strengthening, breathing, posture, proprioceptive, relaxation exercises and segmental extremity movements. Each exercise will be performed 10 times in a session for the first 4 weeks and 15 times for the last 4 weeks. Exercises will be performed progressively on the patients. | Other | Telerehabilitation group |
Primary outcome
Fatigue severity scale
Time frame: 2 minutes
Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7
Hospital Anxiety and Depression Scale
Time frame: 2 minutes
It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety. Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression
2 secondary outcomes
Pittsburg Sleep Quality Index
Time frame: 3 minutes
Health Assessment Questionnaire
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Home tele-rehabilitation for rheumatic patients: impact and satisfaction of care analysisLink provided by the sponsor.
- Efficacy of tele-rehabilitation compared with office-based physical therapy in patients with knee osteoarthritis: A randomized clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Group in people with Telerehabilitation, 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 2 inclusion and 6 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 9 Aug 2022. 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. 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 Songul B Yentur (+90 424 2370000, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (time frame: 2 minutes). The study lists 2 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 9 Aug 2022.