Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jul 30;15(7):e094880.
doi: 10.1136/bmjopen-2024-094880.

Randomised controlled trial of standard outpatient cardiac rehabilitation versus personalised cardiac rehabilitation for secondary prevention for all in need (SPAN) after type 1 myocardial infarction

Tom Gilbert  1 , Julie Redfern  2   3 , Derek P Chew  4 , John Atherton  5 , Graham Hillis  1   6 , Stephen Nicholls  7 , David Brieger  8 , Jamie Rankin  9 , Sam Lehman  10 , Andrew Maiorana  11   12   13 , Charley Budgeon  14 , Anne Cordingley  15 , Teagan Robinson  15 , Tom Briffa  16
Affiliations

Randomised controlled trial of standard outpatient cardiac rehabilitation versus personalised cardiac rehabilitation for secondary prevention for all in need (SPAN) after type 1 myocardial infarction

Tom Gilbert et al. BMJ Open. .

Abstract

Introduction: Cardiac rehabilitation after type 1 myocardial infarction (type 1 MI) is an effective but underutilised method of preventing new cardiac events. This study aims to determine whether a programme of personalised cardiac rehabilitation achieves better completion rates compared with a routine outpatient rehabilitation model post-type 1 MI. A secondary aim is to determine any differences in rates of major adverse cardiovascular events at 12 months.

Methods and analysis: Secondary prevention for all in need (SPAN) is a prospective multisite single-blind comparative effectiveness randomised trial of personalised versus standard outpatient rehabilitation. Five hundred and thirty-two patients with a recent type 1 MI diagnosis will be randomised to either a personalised model of rehabilitation which includes flexibility in the components of rehabilitation and the time and location of contacts, or the standard outpatient model. Exclusion criteria include conditions associated with higher clinical risk to the participant, which introduce confounding to the study or interfere with a participant's ability to comply.The primary study endpoint is the proportion of patients who complete the assigned rehabilitation model. Completion of rehabilitation is defined as participation in ≥80% of all scheduled sessions, in either treatment arm. Assuming a power of 90% and an overall type 1 error of 5%, we expect that 50% of those randomised to usual care will meet the primary endpoint compared with 65% of those on personalised rehabilitation. To detect this difference of 15%, we require a sample size of 478 participants (239 per arm). Accounting for a conservative attrition rate of 10%, the total sample size required is 532.

Ethics and dissemination: The trial received ethical approval from the Southern Adelaide Clinical Human Research Ethics Committee (ref. 2022/HRE00071) in September 2022, with an opt-out approach. The findings will be disseminated through peer-reviewed journals.

Trial registration number: ACTRN12622000316707.

Keywords: CARDIOLOGY; Myocardial infarction; REHABILITATION MEDICINE.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JA declares receiving grants or contracts from American Regent, Bayer, Merck Sharp and Dome, Novo Nordisk; consulting fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Novo Nordisk; payment for presentations from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Novo Nordisk; support attending meetings from Bayer, Bristol-Myers Squibb, Novo Nordisk, Vifor Pharma; leadership or board positions with the Cardiac Society of Australia and New Zealand (CSANZ), National Heart Foundation of Australia (NHFA) Research Committee, Medicare Benefits Schedule Advisory Committee and the Australian Government’s Department of Health and Ageing. TB declares support for attending NHFA meetings. DC declares receiving consulting fees from CSL Sequiris, Novartis and Abbott. JRe declares receiving a peer-reviewed grant from the NHFA and a peer-reviewed fellowship from the National Health and Medical Research Council (NHMRC), and unpaid committee memberships to the World Heart Federation, CSANZ and the Australian Cardiovascular Alliance. All other authors have no completing interest to declare.

Figures

Figure 1
Figure 1. SPAN trial overview. SPAN, secondary prevention for all in need.
Figure 2
Figure 2. Timeline of interventions in SPAN. EQ-5D-5L, EuroQol 5 Dimension 5 Level; MACE, major adverse cardiovascular event.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Australian Institute of Health and Welfare; 2023. Heart, stroke and vascular disease: Australian facts.https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-fact... Available.
    1. Chew DP, Scott IA, Cullen L, et al. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Australian clinical guidelines for the management of acute coronary syndromes 2016. Med J Aust. 2016;205:128–33. doi: 10.5694/mja16.00368. - DOI - PubMed
    1. Abell B, Glasziou P, Briffa T, et al. Exercise training characteristics in cardiac rehabilitation programmes: a cross-sectional survey of Australian practice. Open Heart. 2016;3:e000374. doi: 10.1136/openhrt-2015-000374. - DOI - PMC - PubMed
    1. Redfern J, Maiorana A, Neubeck L, et al. Achieving coordinated secondary prevention of coronary heart disease for all in need (SPAN) Int J Cardiol. 2011;146:1–3. doi: 10.1016/j.ijcard.2010.08.046. - DOI - PubMed
    1. Dibben G, Faulkner J, Oldridge N, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021;11:CD001800. doi: 10.1002/14651858.CD001800.pub4. - DOI - PMC - PubMed

Publication types

LinkOut - more resources