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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorHalmstad University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Axial SpA (ICD10 diagnosis of M45, M46.0, M46.1, M46.8 and M46.9).

Fulfilling recommendations for physical activity

Disqualifiers

Changed TNF and anti-inflammatory medication the previous three months

Cardiovascular disease

Comorbidities making high-intensity training inappropriate

Performing high-intensity interval training on a regular basis

Trial design

Design model

Parallel

Treatments tested in this trial

  • High intensity interval training (HIIT)

    Behavioral

    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

    Other intervention

    Continuing with exercise as usual during 12 months

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HIIT-intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-reported disease activity BASDAI

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)

Time frame
after 3 months
2

Self-reported disease activity BASDAI

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)

Time frame
after 12 months
3

Self-reported disease activity ASDAS-CRP

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)

Time frame
after 3 months
4

Self-reported disease activity ASDAS-CRP

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)

Time frame
after 12 months

Secondary outcomes

1

Aerobic capacity VO2max

VO2max is measured according to Åstrand with a submaximal cycle ergometer test on an indoor stationary bicycle relative to body weight and expressed as the total amount of oxygen metabolized per minute per kilogram of body weight (mL/kg/min)

Time frame
after 3 months
2

Aerobic capacity VO2max

VO2max is measured according to Åstrand with a submaximal cycle ergometer test on an indoor stationary bicycle relative to body weight and expressed as the total amount of oxygen metabolized per minute per kilogram of body weight (mL/kg/min)

Time frame
after 12 months
3

Blood pressure

Blood pressure measured with an automatic blood pressure monitor (Omron M3, Omron Healthcare Co, Mukō, Japan) in millimetres of mercury (mmHg) and is giving numbers of systolic and diastolic pressures

Time frame
after 3 months
4

Blood pressure

Blood pressure measured with an automatic blood pressure monitor (Omron M3, Omron Healthcare Co, Mukō, Japan) in millimetres of mercury (mmHg) and is giving numbers of systolic and diastolic pressures

Time frame
after 12 months

Other outcomes

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