Clinical and arthrosonographic examination of the effect of mechanical stress on entheses before and after fitness training over 12 weeks
Organizational Data
- DRKS-ID:
- DRKS00033607
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2024-02-07
- Last update in DRKS:
- 2024-04-17
- Registration type:
- Prospective
Acronym/abbreviation of the study
BEAT3-Fitness
URL of the study
No Entry
Brief summary in lay language
The aim of this study is to investigate whether mechanical stress (fitness session with a personal trainer) causes inflammation of the tendon insertions and whether this inflammatory reaction can be reduced or disappear completely after 12 weeks of independent training with a Theraband. It is known that mechanical stress can serve as a trigger for psoriatic arthritis, but it is unclear whether regular physical exercise reduces this trigger function. With this study, we would like to better understand the development of inflammation of the tendon insertions and counteract it. Ultrasound is an important tool for detecting inflammation in the tendon insertions. As part of the 18-226-3B study, you will be examined with ultrasound before and after the fitness unit after 12 weeks. This is followed by a clinical joint examination and hand strength measurement, which is study-specific in this setting.
Brief summary in scientific language
Psoriasis is a chronic inflammatory disease with a worldwide prevalence of 0.5-11%. Psoriatic arthritis (PsA) is the most common accompanying symptom of psoriasis and affects around 30% of patients with skin symptoms. The special feature of PsA is the inflammation of the tendon insertions, which is also the focus of the disease. It is now known that patients with only skin symptoms can also have arthrosonographic signs of enthesitis. The prevalence of enthesitis in patients with PsA can be estimated at 35%, which underlines the importance of ultrasound diagnostics and raises the question of the causality of enthesitis, which has not yet been clarified. One hypothesis for the development of enthesitis is mechanical stress, whereby a consecutive tissue reaction can lead to such a pathological reaction. However, it has not yet been investigated whether regular targeted physical exercise can reduce or even prevent mechanical stress-induced enthesitis. The aim of this study is to assess the acute effect of mechanical stress on the entheses in healthy volunteers and in patients with psoriasis and psoriatic arthritis
Health condition or problem studied
- ICD10:
- L40.5 - Arthropathic psoriasis
- ICD10:
- L40 - Psoriasis
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Intervention group: Patients with psoriasis (N= approx. 25) with fitness exercises with Theraband Patients with PsA (N= approx. 25) with fitness exercises with Theraband Healthy subjects (N= approx. 25) with fitness exercises with Theraband
- Arm 2:
- Control group without any intervention: Patients with psoriasis (N= approx. 25) Patients with PsA (N= approx. 25) Healthy subjects (N= approx. 25)
Endpoints
- Primary outcome:
- Quantitative (LEI, SPARCC, MASES scores) and qualitative, arthrosonographic assessment of possible enthesitis in the forearms, patellar tendon insertions and Achilles tendons before and after a strenuous training session in the gym (examinations as part of study 18-226-3B) and after a 12-week training session with Theraband before and after another strenuous training session in the gym (measuring point 1 and measuring point 2) Quantitative and qualitative assessment of maximum strength after repetition on the three machines in the gym selected for activation of the triceps brachii, quadriceps femoris and Achilles tendon after a 12-week training session with Theraband (measurement point 1 after 12 weeks).
- Secondary outcome:
- Quantitative and qualitative assessment of the effects of exercise therapy measures with a fitness band (Theraband) on disease-relevant aspects (including functional ability (HAQ), movement competence (PAHCO), physical activity (BSA, IPAQ), quality of life (SF-36), sleep quality (PSQI), hand strength, fear of movement (TSK)) Quantitative and qualitative recording of clinical parameters such as pain (VAS Pain), inflammation parameters (CRP, BSG) and disease activity (DAS 28, Joint Count 66/68, PASI) after the 12-week training session with a fitness band (Theraband)
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Randomization 1:1 with an Excel Sheet
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Uniklinik Erlangen Erlangen
Recruitment period and number of participants
- Planned study start date:
- 2024-03-01
- Actual study start date:
- 2024-03-01
- Planned study completion date:
- 2025-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 150
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Willingness and ability to participate in the study; sufficient knowledge of German to understand the informed consent form or, if not possible, subject information and support in the native language or, if necessary, in English. High probability that patients will be able to participate in the full scope of the study. A signed informed consent form is required for all subjects to participate in this study (the information and education form is enclosed with the application). For the psoriasis and psoriatic arthritis group, a medical diagnosis of psoriasis or psoriatic arthritis is required.
Exclusion Criteria
Other rheumatic diseases such as rheumatoid arthritis. Pregnancy For psoriasis and psoriatic arthritis patients: no change of systemic immunosuppressive therapy in the last 3 months and during the study period
Addresses
Primary Sponsor
- Address:
- Uniklinik ErlangenDr. Harriet MorfUlmenweg 1891054 ErlangenGermany
- Telephone:
- 09131/8539131
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinik ErlangenDr. Harriet MorfUlmenweg 1891054 ErlangenGermany
- Telephone:
- 09131/8539131
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Uniklinik ErlangenDr. Harriet MorfUlmenweg 1891054 ErlangenGermany
- Telephone:
- 09131/8539131
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Uniklinik ErlangenDr. Harriet MorfUlmenweg 1891054 ErlangenGermany
- Telephone:
- 09131/8539131
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Uniklinik ErlangenUlmenweg 1891054 ErlangenGermany
- Telephone:
- No Entry
- Fax:
- 09131/8539131
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-NürnbergKrankenhausstr. 1291054 ErlangenGermany
- Telephone:
- +40-9131-8522270
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ethikkommission.fau.de
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-07-17
- Ethics committee number:
- 23-272-B
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-09-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The results will be published. The patient data will be summarized and anonymized. The study protocol will be uploaded to the registry and can be viewed at any time. If you have any questions about the study, you can contact us directly by e-mail.
Study protocol and other study documents
- Study protocols:
- Aktuelles Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry