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Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases

NCT04922840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-13

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

High-intensity exercise (HIIT)

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.

Sponsors & Collaborators

  • The Dam Foundation

    collaborator OTHER

  • The Norwegian Rheumatism Association

    collaborator OTHER

  • Norwegian Health Association

    collaborator OTHER

  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Anne Therese Tveter, PhD · National Resource Center for Rehabilitation in Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-12-20
Completion
2023-03-01

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922840 on ClinicalTrials.gov