Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
Condition: Spondyloarthritis; Rheumatoid Arthritis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Joint Diseases
Study type: Interventional

Summary: 
      Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint
      inflammation, pain, stiffness and fatigue. Compared to the general population, this large
      patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related
      mortality. Patients with IJD call for improved CVD screening and risk management as well as
      access to evidence-based non-pharmacological treatment alternatives. Evidence supports high
      intensity training (HIIT) in mitigating risk of CVD and inflammation, but the evidence of
      these cardioprotective benefits is unclear in patients with IJD and the feasibility of HIIT
      protocols in daily clinical care needs to be addressed. Cardiorespiratory fitness (CRF) is an
      important physiological marker and highly correlated to risk of CVD. Despite strong
      recommendations, routine assessment of CRF is seldom performed in clinical care.

      The ExeHeart study will assess the potential cardioprotective and disease-modifying effect of
      HIIT in IJD in a randomized controlled trial. Furthermore, the ExeHeart-study will report on
      the validity of non-exercise measures of cardiorespiratory fitness (eCRF) measures for use in
      daily clinical care. Additionally, we will explore the feasibility of HIIT by addressing
      adherence and fidelity to the HIIT treatment protocol in a primary care setting
    

Detailed description: 
      The study is a two-armed randomized controlled trial (RCT). Patients aged 18-70 years
      presenting with inflammatory joint disease at the Preventive Cardio-Rheuma clinic at
      Diakonhjemmet hospital (Oslo) will be included if eligible for the study. Succeeding baseline
      testing, participants are randomized to either experimental group (high-intensity
      exercise-HIIT) or control group (usual care).

      The research questions are:

        1. Is a 12-week HIIT program effective on VO2peak, inflammatory markers and risk of
           cardiovascular disease in patients with inflammatory joint disease and what is the
           association between VO2peak and disease-specific and cardiovascular disease-related
           variables?

        2. Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining
           longitudinal change in VO2peak in patients with inflammatory joint disease?

        3. How feasible is a HIIT intervention in primary care in patients with inflammatory joint
           disease in terms of adherence and fidelity to the exercise program?

      The primary analysis will be a between group comparison of VO2peak levels. This will be
      carried out according to the intention-to-treat principle, and done by the analysis of
      covariance (ANCOVA), adjusting for VO2peak values at baseline along with stratification
      factors used in the randomization. Secondary analyses will include between group comparisons
      on secondary endpoints, as well as comparisons in the per protocol population. No adjustment
      for multiple testing will be done.

      The association between VO2peak and changes in inflammatory markers, disease activity and CVD
      risk will be assessed using multiple regression.

      The validity of eCRF models to accurately detect longitudinal change in VO2peak from baseline
      to 3-month and 6-month follow-up will be assessed with Pearson or Spearman correlation by
      comparing VO2peak derived from a cardiopulmonary exercise test to eCRF.

      The feasibility of a HIIT program and adherence will be examined with descriptive statistics.
      Adherence to the prescribed HIIT intervention will be recorded by attendance to exercise
      sessions. Quality of treatment delivery will be quantified as the number of exercise sessions
      complying with the planned exercise intensity and number of exercise sessions requiring dose
      modifications such as lower exercise intensity or early session termination. At the 3-month
      timepoint, an electronic questionnaire will be distributed to patients in the HIIT group.
      Questions regarding feasibility and implementation fidelity will address patients'
      acceptability and satisfaction with the HIIT program. The ExeHeart study will also include
      semi-structured interviews, targeting physiotherapists in charge of supervising the exercise
      sessions and 5-7 patients in the intervention group. The interviews will explore barriers and
      facilitators in exercise adherence, experience with the protocol and perceived effects of
      exercise.
    

Intervention name(s): High-intensity exercise (HIIT)
Intervention type(s): Behavioral
Intervention description(s): 12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be allocated 1:1 according to a computer-generated randomization scheme, stratified by sex
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Exercise; Cardiovascular disease; Cardiovascular risk; High-intensity training; Physiotherapy; High-intensity exercise; Inflammatory joint disease