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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05344131
Study groupRoleWhat they receive
The quantitative part of the study (BETY exercise group)Experimentalintervention 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 interventionControl group No intervention
The qualitative part of the studyExperimentalRegularly 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.

  1. 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

  2. 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)
  1. 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.

  2. 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.

  3. 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.

  1. First posted25 Apr 2022
  2. Study start7 Jan 2019
  3. Primary completion30 Aug 2022
  4. Study completion23 Sep 2022

Resources

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)
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

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.

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