High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Control group: Continuing with exercise as usual during 12 months

Study 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.

Eligibility

Primary outcome measure(s)

• Self-reported disease activity BASDAI — after 3 months
  The disease-specific Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) based on six questions on fatigue, pain, tenderness, and morning stiffness measured with numeric questions (range 0-10). The final score is estimated by calculating the mean score 0-10 (best-worse)
• Self-reported disease activity BASDAI — after 12 months
  The disease-specific Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) based on six questions on fatigue, pain, tenderness, and morning stiffness measured with numeric questions (range 0-10). The final score is estimated by calculating the mean score 0-10 (best-worse)
• Self-reported disease activity ASDAS-CRP — after 3 months
  Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Consists of four questions on pain in neck, back, and hip, morning stiffness, well-being, and pain/stiffness in other joints in addition to blood test of CRP. Score 0-4 (\<1.3 inactive disease, \>3,5 very high disease activity). Equation ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)
• Self-reported disease activity ASDAS-CRP — after 12 months
  Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Consists of four questions on pain in neck, back, and hip, morning stiffness, well-being, and pain/stiffness in other joints in addition to blood test of CRP. Score 0-4 (\<1.3 inactive disease, \>3,5 very high disease activity). Equation ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)
• Biomarker C-reaktivt protein (CRP) — after 3 months
  Venous blood to study CRP level by ELISA in µg/ml
• Biomarker C-reaktivt protein (CRP) — after 12 months
  Venous blood to study CRP level by ELISA in µg/ml
• Biomarker Pentraxin-related protein (PTX3) — after 3 months
  Venous blood to study PTX3 by ELISA in µg/ml
• Biomarker Pentraxin-related protein (PTX3) — after 12 months
  Venous blood to study PTX3 by ELISA in µg/ml
• Biomarker serum amyloid A1 — after 3 months
  Venous blood to study serum amyloid A1 by ELISA in µg/ml
• Biomarker serum amyloid A1 — after 12 months
  Venous blood to study serum amyloid A1 by ELISA in µg/ml

Trial sites (1)

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