Rheumatic DiseasesNCT05787340
Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up
A study testing Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) in people with Rheumatic Diseases, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Oct 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the rheumatic disease passed for at least six months after their Covid-19 infection between the ages of 18-65 were included in the study.
Who cannot join
- Exclusion criteria were the presence of deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, severe psychiatric illnesses, and insufficient skills in using a smartphone.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic.
Method: This case study included five patients suffering from Covid-19 infection among patients with rheumatic disease who had acquired the habit of regular exercise before the Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial perspective to see the short and long-term effects of Covid-19 during and after quarantine. Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status, and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression.
Read more
Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of all patients during Covid-19. After six months, although the results from these three scales improved, some of the patients could not return to their pre-covid state.
Conclusions: The patients participating in the telerehabilitation were able to return to everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This study is important in guiding the exercise approach for patients with rheumatic diseases in pandemics such as Covid-19.
- Conditions
- Rheumatic Diseases
- Being tested
- Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)
- Keywords
- Cognitive Exercise Therapy Approach, biopsychosocial exercise, rheumatology rehabilitation, qualitative research, case report
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)Other
Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| BETY exercise group | Experimental | intervention group Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation
Exercise dosage is 60 minute three days a week. Receives: Other: Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative research
We aimed to complete qualitative interviews to investigate the biopsychosocial perspectives of patients with rheumatic diseases in the study. A team of four physiotherapists experienced in rheumatic diseases prepared an interview guide based on prior studies in the literature. The interview guide consisted of 25-item questions from a biopsychosocial perspective to see the short and long-term effects of Covid-19 infection on these patients during and after quarantine.
Measured: at 6 month
Secondary outcomes (3)
Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ)
The scale consists of 30 items. The scoring of the scale was made using a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and gives a total score over 30 items. A high score means that the biopsychosocial situation is 'bad'.
Measured: before infection, during infection and at 6 month after infection
Health Assessment Questionnaire (HAQ)
The functional status of the patients was determined by the Health Assessment Questionnaire. The 20-question scale has 8 subtitles that include dressing, sitting, eating, walking, hygiene, reaching out, grasping, and daily life activities. Each answer is scored between 0 and 3 points. It means "0 = Without difficulty, 1 = A little difficult, 2 = Very difficult and 3 = I can never do it". The total score is the average score derived from 8 points for each category.High score indicates low functional status.
Measured: before infection, during infection and at 6 month after infection
Hospital Anxiety and Depression Scale (HADS)
The anxiety and depression of the patients was determined by Hospital Anxiety and Depression Scale (HADS). This questionnaire is consisting of 14 questions with 4 options. The higher the score, the higher the anxiety and depression levels.
Measured: before infection, during infection and at 6 month after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 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
- Model description
- case series
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787340
- Sponsor's protocol ID
- Kahramanmaras S I U
- Status last verified
- Mar 2023
- First submitted
- 26 Nov 2022
- Last updated
- 28 Mar 2023
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up
- ClinicalTrials.gov ID
- NCT05787340
- Acronym / sponsor ID
- Kahramanmaras S I U
- Conditions
- Rheumatic Diseases
- Keywords
- Cognitive Exercise Therapy Approach, biopsychosocial exercise, rheumatology rehabilitation, qualitative research, case report
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 28 Mar 2023 (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.
Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic.
Method: This case study included five patients suffering from Covid-19 infection among patients with rheumatic disease who had acquired the habit of regular exercise before the Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial perspective to see the short and long-term effects of Covid-19 during and after quarantine. Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status, and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression.
Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of all patients during Covid-19. After six months, although the results from these three scales improved, some of the patients could not return to their pre-covid state.
Conclusions: The patients participating in the telerehabilitation were able to return to everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This study is important in guiding the exercise approach for patients with rheumatic diseases in pandemics such as Covid-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series
| Arm | Type | Receives |
|---|---|---|
| BETY exercise group | Experimental | Other: Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)intervention group Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation Exercise dosage is 60 minute three days a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with the rheumatic disease passed for at least six months after their Covid-19 infection between the ages of 18-65 were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria were the presence of deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, severe psychiatric illnesses, and insufficient skills in using a smartphone.
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 |
|---|---|---|
| Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation. | Other | BETY exercise group |
Primary outcome
Qualitative research
Time frame: at 6 month
We aimed to complete qualitative interviews to investigate the biopsychosocial perspectives of patients with rheumatic diseases in the study. A team of four physiotherapists experienced in rheumatic diseases prepared an interview guide based on prior studies in the literature. The interview guide consisted of 25-item questions from a biopsychosocial perspective to see the short and long-term effects of Covid-19 infection on these patients during and after quarantine.
3 secondary outcomes
Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: before infection, during infection and at 6 month after infection
Health Assessment Questionnaire (HAQ)
Time frame: before infection, during infection and at 6 month after infection
Hospital Anxiety and Depression Scale (HADS)
Time frame: before infection, during infection and at 6 month after infection
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 28 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) in people with Rheumatic Diseases, run by Kahramanmaras Sutcu Imam 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 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 28 Mar 2023. 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?
Qualitative research (time frame: at 6 month). 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 28 Mar 2023.