Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Peak oxygen uptake - VO2peak ml/kg/min
Study Overview
Brief 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:
- 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?
- Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining longitudinal change in VO2peak in patients with inflammatory joint disease?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The trial is single-blinded with investigator (KRN) masked for group allocation to reduce risk of bias. Patients are not blinded to treatment exposure nor study hypothesis.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18-70
- •BMI: 18.5-40
- •Inflammatory joint disease verified by physician
- •Able to walk unaided and continuously for ≥ 15 min.
- •Norwegian or English speaking
Exclusion Criteria
- •Sustained lower extremity injury ≤12 months, including surgery
- •Neurological disease
- •Absolute contraindication to maximal exercise test
- •Cognitive impairment
- •Participation in structured high-intensity exercise ≥ 1/week in the last 3 months
Arms & Interventions
High-intensity exercise (HIIT)
Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication.
The 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor.
Individual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group.
Intervention: High-intensity exercise (HIIT) (Behavioral)
Usual care
Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion.
Outcomes
Primary Outcomes
Peak oxygen uptake - VO2peak ml/kg/min
Time Frame: 3 months post baseline
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Secondary Outcomes
- Body Mass Index(6 months post baseline)
- Low-density lipoproteins(6 months post baseline)
- Dosage of medication(6 months post baseline)
- Triglycerides(6 months post baseline)
- Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline(6 months)
- Change in VO2peak L/min from baseline to 3 months post baseline(3 months post baseline)
- Change in VO2peak L/min from baseline to 6 months post baseline(6 months post baseline)
- Body composition(6 months post baseline)
- Oxygen pulse(6 months post baseline)
- Total cholesterol(6 months post baseline)
- Blood pressure(6 months post baseline)
- Ventilatory threshold 1(6 months post baseline)
- Breathing reserve(6 months post baseline)
- Ventilatory equivalents for carbon dioxide(VE/VCO2)(3 months post baseline)
- Ventilatory equivalents for carbon dioxide (VE/VCO2)(6 months post baseline)
- Peak oxygen uptake - VO2peak L/min(6 months post baseline)
- Peak oxygen uptake - VO2peak ml/kg/min(6 months post baseline)
- Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline(3 months post baseline)
- Respiratory Exchange Ratio (RER)(6 months post baseline)
- Erythrocyte Sedimentation Rate(6 months post baseline)
- Maximum voluntary ventilation (MVV)(6 months post baseline)
- Rheumatoid arthritis impact of disease (RAID)(6 months post baseline)
- Post-exercise questionnaire(3 months post baseline)
- Ventilatory threshold 2(6 months post baseline)
- Ventilatory equivalents for oxygen (VE/VO2)(6 months post baseline)
- Blood lactate concentration(6 months post baseline)
- C-Reactive protein(6 months post baseline)
- High-density lipoproteins(6 months post baseline)
- FEV1/FVC ratio(6 months post baseline)
- Forced expiratory flow(6 months post baseline)
- Psoriatic Arthritis Impact of Disease (PsAID)(6 months post baseline)
- Waist circumference(6 months post baseline)
- Self-reported fatigue(6 months post baseline)
- Self-reported pain(6 months post baseline)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline)
- Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)(6 months post baseline)
- Smoking status(6 months post baseline)
- Exercise frequency(3 months post baseline)
- Resting heart rate(6 months post baseline)
- Self-reported cardiovascular health and symptoms(6 months post baseline)
- Health-related quality of life, EuroQoL (EQ5D-5L)(6 months post baseline)
- Frequency of medication(6 months post baseline)
- Self-reported physical activity (HUNT)(6 months post baseline)
- SCORE2(6 months post baseline)
- Forced vital capacity(6 months post baseline)
- Forced expiratory volume in 1 second (FEV1)(6 months post baseline)
- Peak expiratory flow (PEF)(6 months post baseline)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(6 months post baseline)
- Augmentation index(6 months post baseline)
- Pulse Wave Velocity(6 months post baseline)
- Exercise self-efficacy(6 months post baseline)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(6 months post baseline)
- Bath Ankylosing Spondylitis Global Score (BAS-G)(6 months post baseline)
- Disease Activity in PSoriatic Arthritis (DAPSA)(6 months post baseline)
- Use of healthcare services(6 months post baseline)
- Exercise intensity(3 months post baseline)
- Early session termination(3 months post baseline)
- Corona virus 19 quarantine(6 months post baseline)
- Snuff status(6 months post baseline)
- Peak heart rate(6 months post baseline)
- Exercise duration(3 months post baseline)
- Self-report exercise habits(6 months post baseline)
- Maximum minute ventilation at peak exercise (VEmax, L/min)(6 months post baseline)
- Exercise-related adverse events(3 months post baseline)
- Self-report change in physical fitness(6 months post baseline)
- Corona virus 19 infection(6 months post baseline)
- Peak oxygen uptake - VO2peak L/min(3 months post baseline)
- Peak oxygen uptake - VO2peak ml/kg/min(Baseline)
- Body Mass Index(3 months post baseline)
- Peak oxygen uptake - VO2peak L/min(Baseline)
- Body composition(Baseline)
- Body composition(3 months post baseline)
- Ventilatory threshold 1(Baseline)
- Ventilatory threshold 1(3 months post baseline)
- Ventilatory threshold 2(Baseline)
- Ventilatory threshold 2(3 months post baseline)
- Breathing reserve(Baseline)
- Breathing reserve(3 months post baseline)
- Oxygen pulse(Baseline)
- Oxygen pulse(3 months post baseline)
- Ventilatory equivalents for oxygen (VE/VO2)(Baseline)
- Ventilatory equivalents for oxygen (VE/VO2)(3 months post baseline)
- Ventilatory equivalents for carbon dioxide(VE/VCO2)(Baseline)
- Respiratory Exchange Ratio (RER)(Baseline)
- Respiratory Exchange Ratio (RER)(3 months post baseline)
- Blood lactate concentration(Baseline)
- Blood lactate concentration(3 months post baseline)
- C-Reactive protein(Baseline)
- C-Reactive protein(3 months post baseline)
- Blood pressure(3 months post baseline)
- Erythrocyte Sedimentation Rate(Baseline)
- Erythrocyte Sedimentation Rate(3 months post baseline)
- Total cholesterol(Baseline)
- Total cholesterol(3 months post baseline)
- High-density lipoproteins(Baseline)
- Body Mass Index(Baseline)
- High-density lipoproteins(3 months post baseline)
- Low-density lipoproteins(Baseline)
- Low-density lipoproteins(3 months post baseline)
- Triglycerides(Baseline)
- Triglycerides(3 months post baseline)
- Blood pressure(Baseline)
- Waist circumference(Baseline)
- Waist circumference(3 months post baseline)
- Resting heart rate(Baseline)
- Resting heart rate(3 months post baseline)
- Frequency of medication(3 months post baseline)
- Self-reported fatigue(Baseline)
- Health-related quality of life, EuroQoL (EQ5D-5L)(Baseline)
- Health-related quality of life, EuroQoL (EQ5D-5L)(3 months post baseline)
- Frequency of medication(Baseline)
- Dosage of medication(Baseline)
- Dosage of medication(3 months post baseline)
- Self-reported fatigue(3 months post baseline)
- Self-reported pain(Baseline)
- Self-reported pain(3 months post baseline)
- Self-reported physical activity (HUNT)(Baseline)
- Self-reported physical activity (HUNT)(3 months post baseline)
- SCORE2(Baseline)
- SCORE2(3 months post baseline)
- Forced vital capacity(Baseline)
- Forced vital capacity(3 months post baseline)
- Forced expiratory volume in 1 second (FEV1)(Baseline)
- Forced expiratory volume in 1 second (FEV1)(3 months post baseline)
- FEV1/FVC ratio(Baseline)
- FEV1/FVC ratio(3 months post baseline)
- Forced expiratory flow(Baseline)
- Forced expiratory flow(3 months post baseline)
- Peak expiratory flow (PEF)(Baseline)
- Peak expiratory flow (PEF)(3 months post baseline)
- Maximum voluntary ventilation (MVV)(Baseline)
- Maximum voluntary ventilation (MVV)(3 months post baseline)
- Psoriatic Arthritis Impact of Disease (PsAID)(Baseline)
- Psoriatic Arthritis Impact of Disease (PsAID)(3 months post baseline)
- Rheumatoid arthritis impact of disease (RAID)(Baseline)
- Rheumatoid arthritis impact of disease (RAID)(3 months post baseline)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(3 months post baseline)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(3 months post baseline)
- Bath Ankylosing Spondylitis Global Score (BAS-G)(Baseline)
- Bath Ankylosing Spondylitis Global Score (BAS-G)(3 months post baseline)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(3 months post baseline)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(6 months post baseline)
- Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)(Baseline)
- Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)(3 months post baseline)
- Disease Activity in PSoriatic Arthritis (DAPSA)(Baseline)
- Disease Activity in PSoriatic Arthritis (DAPSA)(3 months post baseline)
- Use of healthcare services(Baseline)
- Use of healthcare services(3 months post baseline)
- Smoking status(Baseline)
- Smoking status(3 months post baseline)
- Snuff status(Baseline)
- Snuff status(3 months post baseline)
- Peak heart rate(Baseline)
- Peak heart rate(3 months post baseline)
- Augmentation index(Baseline)
- Augmentation index(3 months post baseline)
- Pulse Wave Velocity(Baseline)
- Pulse Wave Velocity(3 months post baseline)
- Exercise self-efficacy(Baseline)
- Exercise self-efficacy(3 months post baseline)
- Self-reported cardiovascular health and symptoms(Baseline)
- Self-reported cardiovascular health and symptoms(3 months post baseline)
- Self-report change in physical fitness(3 months post baseline)
- Self-report exercise habits(3 months post baseline)
- Corona virus 19 infection(3 months post baseline)
- Corona virus 19 quarantine(3 months post baseline)
- Maximum minute ventilation at peak exercise (VEmax, L/min)(Baseline)
- Maximum minute ventilation at peak exercise (VEmax, L/min)(3 months post baseline)
Investigators
Anne Therese Tveter
Principal Investigator, Assosiate Professor
Diakonhjemmet Hospital