High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial
NCT05781763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-03-23
Summary
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.
Conditions
- Axial Spondyloarthritis
Interventions
- BEHAVIORAL
-
High intensity interval training (HIIT)
2 HIIT sessions/week in self-selected activity and type of interval-session with in total 15 minutes interval time (85-90% of MHR) with active rest (50-70% of MHR) between intervals for 12 weeks 1 self-selected session at moderate or high-intensity/week for 12 weeks Standardized physical and digital coaching by a physiotherapist
- OTHER
-
Control group
Continuing with exercise as usual during 12 months
Sponsors & Collaborators
-
Halmstad University
lead OTHER
Principal Investigators
-
Haglund, Assoc. prof. · Dept. of Environmental and Biosciences, Halmstad University, Sweden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 67 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-21
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Sweden
Study Locations
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