Rheumatic DiseaseNCT05321901
Telerehabilitation in Women With Rheumatic Disease
A study testing Biopsychosocial Exercise Therapy approach (BETY) in people with Rheumatic Disease, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY), which is a biopsychosocial model, on daily living activities, anxiety, depression, and biopsychosocial conditions through telerehabilitation in rheumatic patients who could not go to the clinics during the… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Rheumatic Disease
- What is being tested?
- Biopsychosocial Exercise Therapy approach (BETY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2020to 17 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with rheumatic disease,
- Participants knew the exercises before attending BETY sessions,
- Participants who could participate in telerehabilitation by following WhatsApp communication were included in the exercise group.
Who cannot join
- Participants with neurological and psychological disorders,
- severe respiratory failure, fractures, infections, cancer, and musculoskeletal pain due to surgery in the last 6 months,
- Vision loss,
- Pregnancy
- Participants who did not agree to volunteer were not included in our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Telerehabilitation Program Based on Biopsychosocial Approach in Women With Rheumatic Disease
This study aims to investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY), which is a biopsychosocial model, on daily living activities, anxiety, depression, and biopsychosocial conditions through telerehabilitation in rheumatic patients who could not go to the clinics during the COVID-19 pandemic.
Read the detailed description
35 female participants with rheumatic disease were included in the study. Among the individuals who participated in face-to-face BETY sessions before, 23 individuals who agreed to exercise with telerehabilitation were divided into 2 groups, the exercise group, and 12 individuals in the control group.
Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attended sessions that lasted for one and a half hours, 3 days a week for 8 weeks, in the company of a physiotherapist over the Whatsapp group. The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously. The investigators managed the individuals according to their exercise number and order, by reminding them of the exercises with explanatory messages and positive energy via Whatsapp group. The participation of the patients in the exercises was followed up with the answers they gave in the Whatsapp group. Patients who did not respond were called by phone and checked to see if they provided continuity. Both the exercise group and the control group continued their drug treatments during this period.
Group 2: Control group: Individuals in the control group continued their routine drugs.
- Conditions
- Rheumatic Disease
- Being tested
- Biopsychosocial Exercise Therapy approach (BETY), Control group
- Keywords
- Rheumatic diseases, Telerehabilitation, Chronic pain, COVID-19, Biopsychosocial Approach
- Medical subject headings
- Rheumatic Diseases, Chronic Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsychosocial Exercise Therapy approach (BETY)Other
The BETY intervention is grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management.
Control groupOther
The control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Telerehabilitation assisted exercise program | Active comparator | The telerehabilitation-assisted exercise program included a Biopsychosocial Exercise Therapy approach (BETY).
The approaches that make up the BETY innovation are grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management.
Tele-rehabilitation group participated in the sessions that lasted for one and a half hours, 3 days a week for 8 weeks, over the Whatsapp group.
The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously. Receives: Other: Biopsychosocial Exercise Therapy approach (BETY) |
| Control Group | Other | The control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Health Assessment Questionnaire at 8 weeks
The Turkish version of the Health Assessment Questionnaire (HAQ), which is frequently used in patients with rheumatism, was used to evaluate their health and disability status.
This questionnaire consists of 20 questions that collect activities of daily living under 8 activity titles, and each answer is given a score between 0 and 3. (0; No difficulty, 1; With some difficulty, 2: With great difficulty, 3: Not at all).
To calculate the total score, these scores are added and divided by 8 based on the highest score in all sections. A high score is interpreted negatively.
Measured: Baseline, 8 weeks
Change from Baseline in Health Anxiety and Depression Scale at 8 weeks
The Turkish version of the Health Anxiety and Depression Scale (HADS) was used to evaluate depression and anxiety levels.
This scale consists of 14 questions, focusing on the last few days. Each question has 4 options. Odd-numbered questions are used for anxiety, even-numbered questions are used to evaluate depression, and 2 separate scores are obtained that can take values between 0-21. While the critical value for anxiety in the sub-title of the scale was 10, it was determined to be 7 for depression.
Measured: Baseline, 8 weeks
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 8 weeks
The Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ), consists of 30 questions. Each of the items in the scale is scored between 0-4 in accordance with the Likert system.
A higher score indicates poor biopsychosocial status (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never).
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start7 Dec 2020
- Primary completion19 Nov 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkin Oğuz SARI, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321901
- Sponsor's protocol ID
- 2020/106
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Telerehabilitation Program Based on Biopsychosocial Approach in Women With Rheumatic Disease
- ClinicalTrials.gov ID
- NCT05321901
- Acronym / sponsor ID
- 2020/106
- Conditions
- Rheumatic Disease
- Keywords
- Rheumatic diseases, Telerehabilitation, Chronic pain, COVID-19, Biopsychosocial Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 11 Apr 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.
This study aims to investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY), which is a biopsychosocial model, on daily living activities, anxiety, depression, and biopsychosocial conditions through telerehabilitation in rheumatic patients who could not go to the clinics during the COVID-19 pandemic.
Detailed description
35 female participants with rheumatic disease were included in the study. Among the individuals who participated in face-to-face BETY sessions before, 23 individuals who agreed to exercise with telerehabilitation were divided into 2 groups, the exercise group, and 12 individuals in the control group.
Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attended sessions that lasted for one and a half hours, 3 days a week for 8 weeks, in the company of a physiotherapist over the Whatsapp group. The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously. The investigators managed the individuals according to their exercise number and order, by reminding them of the exercises with explanatory messages and positive energy via Whatsapp group. The participation of the patients in the exercises was followed up with the answers they gave in the Whatsapp group. Patients who did not respond were called by phone and checked to see if they provided continuity. Both the exercise group and the control group continued their drug treatments during this period.
Group 2: Control group: Individuals in the control group continued their routine drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Telerehabilitation assisted exercise program | Active comparator | Other: Biopsychosocial Exercise Therapy approach (BETY)The telerehabilitation-assisted exercise program included a Biopsychosocial Exercise Therapy approach (BETY). The approaches that make up the BETY innovation are grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management. Tele-rehabilitation group participated in the sessions that lasted for one and a half hours, 3 days a week for 8 weeks, over the Whatsapp group. The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously. |
| Control Group | Other | Other: Control groupThe control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants diagnosed with rheumatic disease,
- Participants knew the exercises before attending BETY sessions,
- Participants who could participate in telerehabilitation by following WhatsApp communication were included in the exercise group.
Key exclusion criteria (5 listed)
- Participants with neurological and psychological disorders,
- severe respiratory failure, fractures, infections, cancer, and musculoskeletal pain due to surgery in the last 6 months,
- Vision loss,
- Pregnancy
- Participants who did not agree to volunteer were not included in our study.
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 |
|---|---|---|
| Biopsychosocial Exercise Therapy approach (BETY)The BETY intervention is grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management. | Other | Experimental Group: Telerehabilitation assisted exercise program |
| Control groupThe control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period. | Other | Control Group |
Primary outcome
Change from Baseline in Health Assessment Questionnaire at 8 weeks
Time frame: Baseline, 8 weeks
The Turkish version of the Health Assessment Questionnaire (HAQ), which is frequently used in patients with rheumatism, was used to evaluate their health and disability status. This questionnaire consists of 20 questions that collect activities of daily living under 8 activity titles, and each answer is given a score between 0 and 3. (0; No difficulty, 1; With some difficulty, 2: With great difficulty, 3: Not at all). To calculate the total score, these scores are added and divided by 8 based on the highest score in all sections. A high score is interpreted negatively.
Change from Baseline in Health Anxiety and Depression Scale at 8 weeks
Time frame: Baseline, 8 weeks
The Turkish version of the Health Anxiety and Depression Scale (HADS) was used to evaluate depression and anxiety levels. This scale consists of 14 questions, focusing on the last few days. Each question has 4 options. Odd-numbered questions are used for anxiety, even-numbered questions are used to evaluate depression, and 2 separate scores are obtained that can take values between 0-21. While the critical value for anxiety in the sub-title of the scale was 10, it was determined to be 7 for depression.
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 8 weeks
Time frame: Baseline, 8 weeks
The Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ), consists of 30 questions. Each of the items in the scale is scored between 0-4 in accordance with the Likert system. A higher score indicates poor biopsychosocial status (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never).
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 22 Apr 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.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu 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 Biopsychosocial Exercise Therapy approach (BETY) in people with Rheumatic Disease, run by Hasan Kalyoncu 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 3 inclusion and 5 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 22 Apr 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?
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?
Change from Baseline in Health Assessment Questionnaire at 8 weeks (time frame: Baseline, 8 weeks). The study lists 3 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 22 Apr 2022.