Rheumatic DiseasesNCT05344131
Investigation of the Effectiveness of a Biopsychosocial-Based Exercise Model in Rheumatic Diseases: A Mixed Methods Research With Patients' Perspectives
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
Biopsychosocial approaches are recommended in rheumatic diseases. Because the nature of these diseases is based on the person's ability to cope with their chronic disease. Moreover, rheumatic diseases, which are included in chronic diseases; It creates a comprehensive picture with loss of function, fatigue, insomnia… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2019to 23 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed rheumatic diseases
- 18 years and over
Who cannot join
- presence of infection and fever, deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, and severe psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Biopsychosocial approaches are recommended in rheumatic diseases. Because the nature of these diseases is based on the person's ability to cope with their chronic disease. Moreover, rheumatic diseases, which are included in chronic diseases; It creates a comprehensive picture with loss of function, fatigue, insomnia, sexual reluctance, negative mood, social isolation and persistent pain accompanying them. This picture requires comprehensive treatments to include the symptoms. For this reason, biopsychosocial models are drawing attention day by day and it is underlined that a holistic approach to rheumatic patients is necessary. For all these negative conditions, exercise offers treatment as an important parameter. However, it seems that no named, exercise-based biopsychosocial models recommended for rheumatic diseases have been encountered. Studies show that cognitive behavioral therapies play a role when it is necessary to approach this patient group holistically. Patients diagnosed with rheumatism, who have applied to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department since 2004, were included in group training where they could do clinical pilates exercises. Dance therapy-authentic movement was added to the exercise program in order to break the physiological connection of the vicious circle between the awareness gained in 2009 and the pain and anxiety. In 2010, the relationship between anxiety and pain led to the addition of knowledge management in sexuality this time. It was published in the form of a rheumatism book in 2014. In 2015, BETY received trademark registration. In this process, the patients learned to manage their inflammatory pain during the day by applying the pain management strategy individually. The exercise program, which was applied for one hour 3 days a week, was created by applying scales for the diagnosis of diseases during the evaluation phase.However, the patients stated that the relevant scales did not show the change in themselves, and that they experienced different changes. During this period, patients were asked to form sentences expressing the characteristics of change. The sentences formed were simplified by removing the same ones. These sentences were tested on rheumatic patients who did not participate in the BETY group. The item pool was formed by making additions related to activities of daily living. The draft was sent to rheumatologists and their opinions were taken. The opinions of the rheumatologists were shared with the patients, and the final version of the items was given in 2017. This scale was started to be applied to individuals with rheumatism who participated in the BETY program. It was also used for evaluation purposes for patients who did not participate in the exercise group but were given a home program after only the first interview. In this process, which formed the basis for the development of a scale, a qualitative study was needed that investigated the recovery characteristics of the patients and the reasons for their persistence in exercise. This qualitative study aims to reveal in detail the change created by an exercise-based biopsychosocial model in patients with rheumatism. Putting all these mentioned processes in writing and presenting them to the literature will be the efficiency of this study.
- Conditions
- Rheumatic Diseases
- Being tested
- Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)
- Keywords
- Biopsychosocial Model, Rheumatic diseases, Qualitative Research, Exercise
- Medical subject headings
- Rheumatic Diseases, Motor Activity
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
Biopsychosocial approach
| Study group | Role | What they receive |
|---|---|---|
| The quantitative part of the study (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.
Exercise dosage is 60 minute three days a week. Receives: Other: Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) |
| The quantitative part of the study (Control group) | No intervention | Control group No intervention |
| The qualitative part of the study | Experimental | Regularly participated in the BETY program for at least one year Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model.
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 methods
We aimed to complete qualitative semi-structured interviews to investigate biopsychosocial perspectives of patients with rheumatic diseases in each arm of the study. Two pre-prepared interview topic guides were developed collaboratively by the research team with the project steering group which included lay members.
Measured: after minimum one year participated BETY group
Quantitative methods - Assessment of biopsychosocial status 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 -12 weeks after.
Secondary outcomes (3)
Quantitative methods - Assessment of functionality 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 -12 weeks after.
Quantitative methods - Assessment of emotional status 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 -12 weeks after.
Quantitative methods - Assessment of quality of life Short Form 36 Health Survey Questionnaire (SF-36)
The quality of life of the patients was evaluated with the SF-36 scale. Separate scores are obtained for each sub-parameter and scores range from 0-100. 100 points indicate good health, 0 points indicate poor health
Measured: before -12 weeks after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start7 Jan 2019
- Primary completion30 Aug 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
- Investigators
- EDİBE Unal, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344131
- Sponsor's protocol ID
- Kahramanmaras SIU
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Unal E, Karaca NB, Saldirdak GA, Albayrak H, Ozcadirci A, Nacar NE, Tufekci O, Buran S, Kiraz S, Cankurtaran O. Investigation of the Effectiveness of a Biopsychosocial-Based Exercise Approach in Rheumatic Diseases: A Mixed Methods Research With Patients' Perspectives. J Eval Clin Pract. 2025 Feb;31(1):e70033. doi: 10.1111/jep.70033.
PubMed 40012067
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of a Biopsychosocial-Based Exercise Model in Rheumatic Diseases: A Mixed Methods Research With Patients' Perspectives
- ClinicalTrials.gov ID
- NCT05344131
- Acronym / sponsor ID
- Kahramanmaras SIU
- Conditions
- Rheumatic Diseases
- Keywords
- Biopsychosocial Model, Rheumatic diseases, Qualitative Research, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 25 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.
Biopsychosocial approaches are recommended in rheumatic diseases. Because the nature of these diseases is based on the person's ability to cope with their chronic disease. Moreover, rheumatic diseases, which are included in chronic diseases; It creates a comprehensive picture with loss of function, fatigue, insomnia, sexual reluctance, negative mood, social isolation and persistent pain accompanying them. This picture requires comprehensive treatments to include the symptoms. For this reason, biopsychosocial models are drawing attention day by day and it is underlined that a holistic approach to rheumatic patients is necessary. For all these negative conditions, exercise offers treatment as an important parameter. However, it seems that no named, exercise-based biopsychosocial models recommended for rheumatic diseases have been encountered. Studies show that cognitive behavioral therapies play a role when it is necessary to approach this patient group holistically. Patients diagnosed with rheumatism, who have applied to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department since 2004, were included in group training where they could do clinical pilates exercises. Dance therapy-authentic movement was added to the exercise program in order to break the physiological connection of the vicious circle between the awareness gained in 2009 and the pain and anxiety. In 2010, the relationship between anxiety and pain led to the addition of knowledge management in sexuality this time. It was published in the form of a rheumatism book in 2014. In 2015, BETY received trademark registration. In this process, the patients learned to manage their inflammatory pain during the day by applying the pain management strategy individually. The exercise program, which was applied for one hour 3 days a week, was created by applying scales for the diagnosis of diseases during the evaluation phase.However, the patients stated that the relevant scales did not show the change in themselves, and that they experienced different changes. During this period, patients were asked to form sentences expressing the characteristics of change. The sentences formed were simplified by removing the same ones. These sentences were tested on rheumatic patients who did not participate in the BETY group. The item pool was formed by making additions related to activities of daily living. The draft was sent to rheumatologists and their opinions were taken. The opinions of the rheumatologists were shared with the patients, and the final version of the items was given in 2017. This scale was started to be applied to individuals with rheumatism who participated in the BETY program. It was also used for evaluation purposes for patients who did not participate in the exercise group but were given a home program after only the first interview. In this process, which formed the basis for the development of a scale, a qualitative study was needed that investigated the recovery characteristics of the patients and the reasons for their persistence in exercise. This qualitative study aims to reveal in detail the change created by an exercise-based biopsychosocial model in patients with rheumatism. Putting all these mentioned processes in writing and presenting them to the literature will be the efficiency of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The quantitative part of the study (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. Exercise dosage is 60 minute three days a week. |
| The quantitative part of the study (Control group) | No intervention | –Control group No intervention |
| The qualitative part of the study | Experimental | Other: Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)Regularly participated in the BETY program for at least one year Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model. Exercise dosage is 60 minute three days a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed rheumatic diseases
- 18 years and over
Key exclusion criteria (1 listed)
- presence of infection and fever, deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, and severe psychiatric illnesses.
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)Biopsychosocial approach | Other | The qualitative part of the study, The quantitative part of the study (BETY exercise group) |
Primary outcome
Qualitative methods
Time frame: after minimum one year participated BETY group
We aimed to complete qualitative semi-structured interviews to investigate biopsychosocial perspectives of patients with rheumatic diseases in each arm of the study. Two pre-prepared interview topic guides were developed collaboratively by the research team with the project steering group which included lay members.
Quantitative methods - Assessment of biopsychosocial status Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: before -12 weeks after.
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'.
3 secondary outcomes
Quantitative methods - Assessment of functionality Health Assessment Questionnaire (HAQ)
Time frame: before -12 weeks after.
Quantitative methods - Assessment of emotional status Hospital Anxiety and Depression Scale (HADS)
Time frame: before -12 weeks after.
Quantitative methods - Assessment of quality of life Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: before -12 weeks after.
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 25 Apr 2024.
- Derived from this study: PubMed 40012067Unal E, Karaca NB, Saldirdak GA, Albayrak H, Ozcadirci A, Nacar NE, Tufekci O, Buran S, Kiraz S, Cankurtaran O. Investigation of the Effectiveness of a Biopsychosocial-Based Exercise Approach in Rheumatic Diseases: A Mixed Methods Research With Patients' Perspectives. J Eval Clin Pract. 2025 Feb;31(1):e70033. doi: 10.1111/jep.70033.
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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.
EDİBE Unal study director
Hacettepe 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 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 2 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 25 Apr 2024. 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 methods (time frame: after minimum one year participated BETY group). 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?
On the ClinicalTrials.gov record for NCT05344131, which also lists 1 linked publication.
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 25 Apr 2024.