Rheumatic DiseasesNCT05568485
Telerehabilitation in Individuals With Rheumatic Disease
A study testing Telerehabilitation was applied to the group with rheumatism in people with Rheumatic Diseases, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Telerehabilitation was applied to the group with rheumatism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Dec 2020to 20 Dec 2021
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.
Who cannot join
- Individuals who had difficulty in cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic
increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the COVID-19 pandemic.
Read the detailed description
Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. This exercise content was based on a biopsychosocial model, named the Cognitive Exercise Therapy Approach (BETY) which was used in the study, and it was a method that patients already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.
- Conditions
- Rheumatic Diseases
- Being tested
- Telerehabilitation was applied to the group with rheumatism
- Keywords
- Biopsychosocial, rheumatology, remote care, holistic
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation was applied to the group with rheumatismOther
Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therap
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Telerehabilitation was applied to the group with rheumatism Receives: Other: Telerehabilitation was applied to the group with rheumatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY Biopsychosocial Questionnaire (BETY-BQ
an assessment tool that evaluates biopsychosocial involvement and assesses pain, function, sexual behavior, and social and psychological aspects. The scoring of the questionnaire is made using a 5-point Likert system. Each item is scored as "0 = No, never, 1 = Yes, rarely, 2 = Yes, sometimes, 3 = Yes, often, or 4 = Yes, always". A high score indicates a low biopsychosocial status
Measured: change will be assessed at 12th week and 24th week
Secondary outcomes (2)
Health assessment questionnaire
It includes 20 questions and 8 components including dressing, sitting, eating, walking, hygiene, reaching out, comprehending, and activities of daily living. Each answer is rated between 0 and 3 points, "0 = No difficulty, 1 = Somewhat difficult, 2 = Very difficult, and 3 = I can never do it", and a high score indicates low functionality [18]. HAQ scores of >1 are considered to indicate the presence of disability
Measured: change will be assessed at 12th week and 24th week
hospital qnxiety and depression scale
. It is a 14-item scale that consists of Anxiety (HADS-A) and Depression (HADS-D) subscales. The answer to each item is scored between 0 and 3 using the 4-point Likert scoring format, and each subscale has a score range between 0 and 21. Scores between 0 and 7 for each subscale are considered "normal", those between 8 and 10 are considered "mild anxiety/depression", and those from 11 to 21 are considered moderate-severe anxiety/depression
Measured: change will be assessed at 12th week and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Dec 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Öksüz, Eastern Mediterranean University
- Investigators
- Zeynep İrem Bulut, MSc. Pt., Principal investigator, Hasan Kalyoncu UniversityNur Banu Karaca, MSc. Pt., Principal investigator, Hacettepe UniversityArzu Dağ, Principal investigator, İstanbul Yeni Yüzyıl UniversityYavuz Yakut, Prof.Dr., Study director, Hasan Kalyoncu UniversitySedat Kiraz, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568485
- Sponsor's protocol ID
- GO-18/1182
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2022
- Last updated
- 13 Oct 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05568485
- Acronym / sponsor ID
- GO-18/1182
- Conditions
- Rheumatic Diseases
- Keywords
- Biopsychosocial, rheumatology, remote care, holistic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 5 Oct 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.
increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the COVID-19 pandemic.
Detailed description
Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. This exercise content was based on a biopsychosocial model, named the Cognitive Exercise Therapy Approach (BETY) which was used in the study, and it was a method that patients already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Telerehabilitation was applied to the group with rheumatismTelerehabilitation was applied to the group with rheumatism |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.
Key exclusion criteria (1 listed)
- Individuals who had difficulty in cooperation
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 was applied to the group with rheumatismTelerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therap | Other | Telerehabilitation |
Primary outcome
BETY Biopsychosocial Questionnaire (BETY-BQ
Time frame: change will be assessed at 12th week and 24th week
an assessment tool that evaluates biopsychosocial involvement and assesses pain, function, sexual behavior, and social and psychological aspects. The scoring of the questionnaire is made using a 5-point Likert system. Each item is scored as "0 = No, never, 1 = Yes, rarely, 2 = Yes, sometimes, 3 = Yes, often, or 4 = Yes, always". A high score indicates a low biopsychosocial status
2 secondary outcomes
Health assessment questionnaire
Time frame: change will be assessed at 12th week and 24th week
hospital qnxiety and depression scale
Time frame: change will be assessed at 12th week and 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Zeynep İrem Bulut, MSc. Pt. principal investigator
Hasan Kalyoncu University
Nur Banu Karaca, MSc. Pt. principal investigator
Hacettepe University
Arzu Dağ principal investigator
İstanbul Yeni Yüzyıl 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 Telerehabilitation was applied to the group with rheumatism in people with Rheumatic Diseases, run by Eastern Mediterranean University at 1 site in Cyprus.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 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 Cyprus. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY Biopsychosocial Questionnaire (BETY-BQ (time frame: change will be assessed at 12th week and 24th week). 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 13 Oct 2022.