| Literature DB >> 29574443 |
Stuart Ennis1,2, Grace Lobley1, Sandra Worrall1, Richard Powell1, Peter K Kimani3, Amir Jahan Khan4, Prithwish Banerjee4,5, Thomas Barker6, Gordon McGregor1,4.
Abstract
INTRODUCTION: Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy. METHODS AND ANALYSIS: In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2-3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03223558; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.Entities:
Keywords: cardiovascular fitness; coronary artery bypass graft; coronary heart disease; muscle atrophy; valve replacement
Mesh:
Year: 2018 PMID: 29574443 PMCID: PMC5875596 DOI: 10.1136/bmjopen-2017-019748
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Inclusion and exclusion criteria
| Inclusion criteria | Exclusion criteria |
|
Coronary artery bypass graft and mitral/aortic valve replacement patients recovering from sternotomy and eligible for cardiac rehabilitation exercise training in accordance with UK standards Able to provide written informed consent; Male or female; 18–90 years of age. |
Serious cardiac arrhythmias; Current neurological disorders or previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise; Unable to enrol for the full study duration; Inability to comply with guidelines for participation in exercise training Significant limiting comorbidities that would prevent full participation. |
Figure 1Trial flow chart—University Hospitals Coventry and Warwickshire. *Assessment to include: 6 min walk, five times sit-to-stand, grip strength, isometric leg strength, Generalised Anxiety Disorder assessment, Patient Health Questionnaire, 12-Item Short Form Survey, 5-Item EuroQol, Client Service Receipt Inventory. CR, cardiac rehabilitation.
Outcome measures and schedule of assessments
| Measure | Instrument | Assessment time point |
| Walking distance | 6 min walk test | Baseline, start CR, end CR, 12 months |
| Functional fitness | Five times sit-to-stand | Baseline, start CR, end CR, 12 months |
| Handgrip strength | Baseline, start CR, end CR, 12 months | |
| Isometric leg strength | Baseline, start CR, end CR, 12 months | |
| Anxiety and depression | GAD-7 | Baseline, start CR, end CR, 12 months |
| PHQ-9 | Baseline, start CR, end CR, 12 months | |
| HR-QOL | SF-12 | Baseline, start CR, end CR, 12 months |
| Compliance, adherence | Compliance/ | Continuous |
| Cost-effectiveness | EQ-5D | Baseline, start CR, end CR, 12 months |
| CSRI | Start CR, end CR, 12 months | |
| Safety | Adverse event monitoring | Continuous |
CR, cardiac rehabilitation; CSRI, Client Service Receipt Inventory.; EQ-5D, 5-Item EuroQol; GAD-7, Generalised Anxiety Disorder assessment; HR-QoL, health-related quality of life; PHQ-9, Patient Health Questionnaire; SF-12. 12-Item Short Form Survey.
Resource use and intervention cost measures
| Measure | Instrument | Assessment time point |
| Secondary care | ||
| Number and length of admissions | CSRI | Start CR, end CR, 12 months |
| Emergency care | ||
| Number of visits to A&E. | CSRI | Start CR, end CR, 12 months |
| Primary care | ||
| Type of professional seen. | CSRI | Start CR, end CR, 12 months |
| Healthcare at home | ||
| Type of professional seen. | CSRI | Start CR, end CR, 12 months |
| Medication | ||
| Name/class/dose. | CSRI | Start CR, end CR, 12 months |
| Cost of intervention | ||
| Staff, equipment, facility. | Cost diary | Every participant contact |
A&E, accident and emergency; CR, cardiac rehabilitation; CSRI, Client Service Receipt Inventory.