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Abstract
Introduction Patients with systemic inflammatory diseases such as rheumatoid arthritis (RA) have an increased risk of cardiovascular disease (CVD) above the baseline risk attributable to traditional CVD risk factors seen in the general population. Exercise in cardiac rehabilitation (CR) is designed specifically for high-risk primary prevention and those with established CVD. Even though the European League Against Rheumatism guidelines state that exercise is safe for individuals with RA and exercise can reduce CVD risk, patients with RA rarely participate in CR. Thus, little is known about CR’s impact on inflammatory and CVD risk in the RA population. The purpose of this trial is to determine the feasibility of a 12-week CR programme for patients with RA and whether it decreases CVD risk without exacerbating RA.
Methods and analysis This is a randomised controlled trial whereby 60 participants with RA will be recruited and randomly assigned to either standard of care (SOC) treatment or SOC plus a 12-week CR programme (60 min of education plus two 60 min aerobic exercise sessions/week). Exercise will be performed at 60%–80% of heart rate reserve. Outcome measures (Framingham Risk Score, resting heart rate, blood pressure, blood lipids, markers of systemic inflammation (ie, interleukin (IL) 6 and tumour necrosis factor-α (TNF-α), Clinical Disease Assessment Index, Disease Activity Score-28, physical activity levels and peak cardiorespiratory fitness) will be assessed preintervention (week-0), postintervention (week-13) and 6 months postintervention.
Ethics and dissemination Ethical approval was obtained from the Nova Scotia Health Authority Research Ethics Board. Results will be submitted for publication in an appropriate peer-reviewed journal.
Trial registration number NCT01534871; Pre-results
- cardiovascular disease
- inflammation
- rehumatoid arthritis
- exercise
- rehabilitation medicine
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors SH-M has made substantial contributions to the acquisition, analysis and interpretation of the data, as well as drafting and critically revising the manuscript. SAG, NG and VB conceived and designed the trial and critically revised the manuscript. All authors have approved the final version of the manuscript and have agreed to be accountable for all aspects of the work.
Funding Funding for this study is provided by the Nova Scotia Health Research Foundation (Med-Research Programs-2012-8739).
Disclaimer The funder was not involved in the study design and is not involved with the implementation of study (eg, data collection, data analysis, interpretation and knowledge translation).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Nova Scotia Health Authority Research Ethics Board (REB#2012–355).
Provenance and peer review Not commissioned; externally peer reviewed.