NCT05781763Recruiting
High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial
High-intensity Exercise Based on Self-management With Digital Coaching in Patients With Spondyloarthritis: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Project summary Background: For people diagnosed with a spondyloarthritis (SpA) e.g. ankylosing spondylitis or undifferentiated spondyloarthritis, physical activity and exercise are important components in the self-management. Exercise, in addition to physical and mental symptoms related to the disease can easily feel overwhelming to exercise, and low adherence may result. By studying the effects of high-intensity interval training (HIIT) in comparison with training as usual on physiological, inflammatory, and self-reported disease parameters in patients with SpA, we intend to further investigate the short-term and longitudinal training effects, and refine the knowledge to tailor, coach, and stimulate to self-performed HIIT. Objective: The purpose of this study is to investigate the short- and long-term effects of high- intensity interval training (HIIT) on physiological, inflammatory, and self-reported health parameters in patients with SpA. The aim is also to study the adherence to physical activity and exercise recommendations. Design: A randomized controlled trial (RCT) design. Participants: One hundred adults with a confirmed axial SpA from rheumatology clinics in southern Sweden will be recruited and randomized into two groups, the intervention group and the control group. Intervention: Three high-intensity training sessions per week for three months, of which two interval sessions, with coaching both from a clinical physiotherapist and digital devices (watch and app) followed by nine months with sporadic coaching. The control group will go on with exercise as usual. Primary outcome: Self-reported disease activity, inflammatory biomarkers (acute phase proteins). Secondary outcomes: Physical fitness (aerobic capacity (VO2max), blood pressure, grep strength), body composition and self-reported physical function, health status, well-being, pain, fatigue, adherence to physical activity and exercise recommendations, and confidence in one's own ability to manage pain, symptoms and high-intensity exercise, and additional serum biomarkers.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Feb 2023
- Start date
- 21 Mar 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Halmstad University
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05781763
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 21 Mar 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Changed TNF and anti-inflammatory medication the previous three months
Other illness
- Cardiovascular disease
Other
- Comorbidities making high-intensity training inappropriate
- Performing high-intensity interval training on a regular basis
Who the study is looking for
- Axial SpA (ICD10 diagnosis of M45, M46.0, M46.1, M46.8 and M46.9).
- Fulfilling recommendations for physical activity
Age in the registry: 18 years to 67 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Halmstad University Coordinator of this site? Confirm its status | Halmstad | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.