Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study
Abstract Objectives Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population. Design We undertook a pilot ra...
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Online Access: | http://link.springer.com/article/10.1186/s40814-018-0363-8 |
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doaj-c68c250e9e424018b07d76dfe197a8d72020-11-25T02:14:11ZengBMCPilot and Feasibility Studies2055-57842018-12-01411910.1186/s40814-018-0363-8Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility studyPaula Rogers0Sayed Al-Aidrous1Winston Banya2Shelley Rahman Haley3Tarun Mittal4Tito Kabir5Vasileois Panoulas6Shahzad Raja7Sunil Bhudia8Heather Probert9Claire Prendergast10Mark S. Spence11Simon Davies12Neil Moat13Rod S. Taylor14Miles Dalby15Royal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Victoria HospitalRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeInstitute of Health Research, University of Exeter Medical School, Exeter & The School of Medicine, Dentistry & Nursing, University of GlasgowRoyal Brompton & Harefield NHS Foundation Trust London, Imperial CollegeAbstract Objectives Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population. Design We undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT). Participants We screened patients undergoing TAVI at a single institution between June 2016 and February 2017. Interventions Participants were randomised post-TAVI to standard of care (control group) or standard of care plus exercise-based CR (intervention group). Outcomes We assessed recruitment and attrition rates, uptake of CR, and explored changes in 6-min walk test, Nottingham Activities of Daily Living, Fried and Edmonton Frailty scores and Hospital Anxiety and Depression Score, from baseline (30 days post TAVI) to 3 and 6 months post randomisation. We also undertook a parallel study to assess the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the post-TAVI population. Results Of 82 patients screened, 52 met the inclusion criteria and 27 were recruited (3 patients/month). In the intervention group, 10/13 (77%) completed the prescribed course of 6 sessions of CR (mean number of sessions attended 7.5, SD 4.25) over 6 weeks. At 6 months, all participants were retained for follow-up. There was apparent improvement in outcome scores at 3 and 6 months in control and CR groups. There were no recorded adverse events associated with the intervention of CR. The KCCQ was well accepted in 38 post-TAVI patients: mean summary score 72.6 (SD 22.6). Conclusions We have demonstrated the feasibility of recruiting post-TAVI patients into a randomised trial of CR. We will use the findings of this pilot trial to design a fully powered multicentre RCT to inform the provision of CR and support guideline development to optimise health-related quality of life outcomes in this vulnerable population. Retrospectively registered 3rd October 2016 clinicaltrials.gov NCT02921880. Trial registration Clinicaltrials.Gov identifier NCT02921880http://link.springer.com/article/10.1186/s40814-018-0363-8Cardiac rehabilitationTranscatheter aortic valve implantationRandomised controlled trialPilot study |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Paula Rogers Sayed Al-Aidrous Winston Banya Shelley Rahman Haley Tarun Mittal Tito Kabir Vasileois Panoulas Shahzad Raja Sunil Bhudia Heather Probert Claire Prendergast Mark S. Spence Simon Davies Neil Moat Rod S. Taylor Miles Dalby |
spellingShingle |
Paula Rogers Sayed Al-Aidrous Winston Banya Shelley Rahman Haley Tarun Mittal Tito Kabir Vasileois Panoulas Shahzad Raja Sunil Bhudia Heather Probert Claire Prendergast Mark S. Spence Simon Davies Neil Moat Rod S. Taylor Miles Dalby Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study Pilot and Feasibility Studies Cardiac rehabilitation Transcatheter aortic valve implantation Randomised controlled trial Pilot study |
author_facet |
Paula Rogers Sayed Al-Aidrous Winston Banya Shelley Rahman Haley Tarun Mittal Tito Kabir Vasileois Panoulas Shahzad Raja Sunil Bhudia Heather Probert Claire Prendergast Mark S. Spence Simon Davies Neil Moat Rod S. Taylor Miles Dalby |
author_sort |
Paula Rogers |
title |
Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
title_short |
Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
title_full |
Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
title_fullStr |
Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
title_full_unstemmed |
Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
title_sort |
cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2018-12-01 |
description |
Abstract Objectives Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population. Design We undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT). Participants We screened patients undergoing TAVI at a single institution between June 2016 and February 2017. Interventions Participants were randomised post-TAVI to standard of care (control group) or standard of care plus exercise-based CR (intervention group). Outcomes We assessed recruitment and attrition rates, uptake of CR, and explored changes in 6-min walk test, Nottingham Activities of Daily Living, Fried and Edmonton Frailty scores and Hospital Anxiety and Depression Score, from baseline (30 days post TAVI) to 3 and 6 months post randomisation. We also undertook a parallel study to assess the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the post-TAVI population. Results Of 82 patients screened, 52 met the inclusion criteria and 27 were recruited (3 patients/month). In the intervention group, 10/13 (77%) completed the prescribed course of 6 sessions of CR (mean number of sessions attended 7.5, SD 4.25) over 6 weeks. At 6 months, all participants were retained for follow-up. There was apparent improvement in outcome scores at 3 and 6 months in control and CR groups. There were no recorded adverse events associated with the intervention of CR. The KCCQ was well accepted in 38 post-TAVI patients: mean summary score 72.6 (SD 22.6). Conclusions We have demonstrated the feasibility of recruiting post-TAVI patients into a randomised trial of CR. We will use the findings of this pilot trial to design a fully powered multicentre RCT to inform the provision of CR and support guideline development to optimise health-related quality of life outcomes in this vulnerable population. Retrospectively registered 3rd October 2016 clinicaltrials.gov NCT02921880. Trial registration Clinicaltrials.Gov identifier NCT02921880 |
topic |
Cardiac rehabilitation Transcatheter aortic valve implantation Randomised controlled trial Pilot study |
url |
http://link.springer.com/article/10.1186/s40814-018-0363-8 |
work_keys_str_mv |
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