Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
ExeHeart
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 13, 2023
March 1, 2023
1.4 years
May 15, 2021
March 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen uptake - VO2peak ml/kg/min
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
3 months post baseline
Secondary Outcomes (170)
Peak oxygen uptake - VO2peak L/min
3 months post baseline
Peak oxygen uptake - VO2peak ml/kg/min
Baseline
Peak oxygen uptake - VO2peak ml/kg/min
6 months post baseline
Peak oxygen uptake - VO2peak L/min
Baseline
Peak oxygen uptake - VO2peak L/min
6 months post baseline
- +165 more secondary outcomes
Study Arms (2)
High-intensity exercise (HIIT)
EXPERIMENTALUsual 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.
Usual care
NO INTERVENTIONControl 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diakonhjemmet Hospitallead
- The Dam Foundationcollaborator
- The Norwegian Rheumatism Associationcollaborator
- Norwegian Health Associationcollaborator
Study Sites (1)
Diakonhjemmet Hospital
Oslo, Norway
Related Publications (3)
Norden KR, Semb AG, Dagfinrud H, Hisdal J, Sexton J, Fongen C, Bakke E, Odegard S, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity interval training in physiotherapy primary care for patients with inflammatory arthritis: the ExeHeart randomised controlled trial. RMD Open. 2024 Jan 18;10(1):e003440. doi: 10.1136/rmdopen-2023-003440.
PMID: 38242550DERIVEDNorden KR, Semb AG, Dagfinrud H, Hisdal J, Odegard S, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Associations between cardiovascular risk factors, disease activity and cardiorespiratory fitness in patients with inflammatory joint disease: a cross-sectional analysis. BMC Sports Sci Med Rehabil. 2023 Apr 21;15(1):63. doi: 10.1186/s13102-023-00678-4.
PMID: 37085935DERIVEDNorden KR, Dagfinrud H, Semb AG, Hisdal J, Viktil KK, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial. BMJ Open. 2022 Feb 17;12(2):e058634. doi: 10.1136/bmjopen-2021-058634.
PMID: 35177467DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Therese Tveter, PhD
National Resource Center for Rehabilitation in Rheumatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Assosiate Professor
Study Record Dates
First Submitted
May 15, 2021
First Posted
June 11, 2021
Study Start
August 9, 2021
Primary Completion
December 20, 2022
Study Completion
March 1, 2023
Last Updated
March 13, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
Data may be made available upon sound request to the principal investigator