Kari Nytrøen1,2,3,4, Katrine Rolid1,2,3,5,4, Arne Kristian Andreassen1,2, Marianne Yardley1,2,5, Einar Gude1,3,4, Dag Olav Dahle6, Elisabeth Bjørkelund1, Anne Relbo Authen1, Ingelin Grov1, Julia Philip Wigh7, Christian Have Dall8,9, Finn Gustafsson9,10, Kristjan Karason7, Lars Gullestad1,2,3,4. 1. Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway. 2. Institute of Clinical Medicine, Faculty of Medicine (K.N., K.R., A.K.A., M.Y., L.G.), University of Oslo, Norway. 3. KG Jebsen Center for Cardiac Research (K.N., K.R., E.G., L.G.), University of Oslo, Norway. 4. Center for Heart Failure Research, Oslo University Hospital, Norway (K.N., K.R., E.G., L.G.). 5. Norwegian Health Association, Oslo, Norway (K.R., M.Y.). 6. Transplantation Medicine (D.O.D.), Oslo University Hospital Rikshospitalet, Norway. 7. Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden (J.P.W., K.K.). 8. Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark (C.H.D.). 9. University of Copenhagen, Denmark (C.H.D., F.G.). 10. Rigshospitalet, Copenhagen, Denmark (F.G.).
Abstract
BACKGROUND: There is no consensus on how, when, or at what intensity exercise should be performed after heart transplantation (HTx). We have recently shown that high-intensity interval training (HIT) is safe, well tolerated, and efficacious in the maintenance state after HTx, but studies have not investigated HIT effects in the de novo HTx state. We hypothesized that HIT could be introduced early after HTx and that it could lead to clinically meaningful increases in exercise capacity and health-related quality of life. METHODS: This multicenter, prospective, randomized, controlled trial included 81 patients a mean of 11 weeks (range, 7-16 weeks) after an HTx. Patients were randomized 1:1 to 9 months of either HIT (4×4-minute intervals at 85%-95% of peak effort) or moderate-intensity continuous training (60%-80% of peak effort). The primary outcome was the effect of HIT versus moderate-intensity continuous training on the change in aerobic exercise capacity, assessed as the peak oxygen consumption (Vo2peak). Secondary outcomes included tolerability, safety, adverse events, isokinetic muscular strength, body composition, health-related quality of life, left ventricular function, hemodynamics, endothelial function, and biomarkers. RESULTS: From baseline to follow-up, 96% of patients completed the study. There were no serious exercise-related adverse events. The population comprised 73% men, and the mean±SD age was 49±13 years. At the 1-year follow-up, the HIT group demonstrated greater improvements than the moderate-intensity continuous training group; the groups showed significantly different changes in the Vo2peak (mean difference between groups, 1.8 mL·kg-1·min-1), the anaerobic threshold (0.28 L/min), the peak expiratory flow (11%), and the extensor muscle exercise capacity (464 J). The 1.8-mL·kg-1·min-1 difference was equal to ≈0.5 metabolic equivalents, which is regarded as clinically meaningful and relevant. Health-related quality of life was similar between the groups, as indicated by results from the Short Form-36 (version 2), Hospital Anxiety and Depression Scale, and a visual analog scale. CONCLUSIONS: We demonstrated that HIT was a safe, efficient exercise method in de novo HTx recipients. HIT, compared with moderate-intensity continuous training, resulted in a clinically significantly greater change in exercise capacity based on the Vo2peak values (25% versus 15%), anaerobic threshold, peak expiratory flow, and muscular exercise capacity. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier NCT01796379.
RCT Entities:
BACKGROUND: There is no consensus on how, when, or at what intensity exercise should be performed after heart transplantation (HTx). We have recently shown that high-intensity interval training (HIT) is safe, well tolerated, and efficacious in the maintenance state after HTx, but studies have not investigated HIT effects in the de novo HTx state. We hypothesized that HIT could be introduced early after HTx and that it could lead to clinically meaningful increases in exercise capacity and health-related quality of life. METHODS: This multicenter, prospective, randomized, controlled trial included 81 patients a mean of 11 weeks (range, 7-16 weeks) after an HTx. Patients were randomized 1:1 to 9 months of either HIT (4×4-minute intervals at 85%-95% of peak effort) or moderate-intensity continuous training (60%-80% of peak effort). The primary outcome was the effect of HIT versus moderate-intensity continuous training on the change in aerobic exercise capacity, assessed as the peak oxygen consumption (Vo2peak). Secondary outcomes included tolerability, safety, adverse events, isokinetic muscular strength, body composition, health-related quality of life, left ventricular function, hemodynamics, endothelial function, and biomarkers. RESULTS: From baseline to follow-up, 96% of patients completed the study. There were no serious exercise-related adverse events. The population comprised 73% men, and the mean±SD age was 49±13 years. At the 1-year follow-up, the HIT group demonstrated greater improvements than the moderate-intensity continuous training group; the groups showed significantly different changes in the Vo2peak (mean difference between groups, 1.8 mL·kg-1·min-1), the anaerobic threshold (0.28 L/min), the peak expiratory flow (11%), and the extensor muscle exercise capacity (464 J). The 1.8-mL·kg-1·min-1 difference was equal to ≈0.5 metabolic equivalents, which is regarded as clinically meaningful and relevant. Health-related quality of life was similar between the groups, as indicated by results from the Short Form-36 (version 2), Hospital Anxiety and Depression Scale, and a visual analog scale. CONCLUSIONS: We demonstrated that HIT was a safe, efficient exercise method in de novo HTx recipients. HIT, compared with moderate-intensity continuous training, resulted in a clinically significantly greater change in exercise capacity based on the Vo2peak values (25% versus 15%), anaerobic threshold, peak expiratory flow, and muscular exercise capacity. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier NCT01796379.
Authors: Juliana Andrade Ferreira de Souza; Bruna T S Araújo; Gustavo Henrique Correia de Lima; Armèle Dornelas de Andrade; Shirley Lima Campos; Maria Inês Remígio de Aguiar; Rodrigo Moreno Dias Carneiro; Daniella Cunha Brandão Journal: Heart Fail Rev Date: 2020-05 Impact factor: 4.214
Authors: Jung-Min Ahn; Frederik M Zimmermann; Satish Arora; Ole-Geir Solberg; Oskar Angerås; Katrine Rolid; Muzammil Rafique; Lars Aaberge; Kristjan Karason; Kozo Okada; Helen Luikart; Kiran K Khush; Yasuhiro Honda; Nico H J Pijls; Sang Eun Lee; Jae-Joong Kim; Seung-Jung Park; Lars Gullestad; William F Fearon Journal: Eur Heart J Date: 2021-12-21 Impact factor: 35.855
Authors: Juliana Beust de Lima; Douglas Dos Santos Soares; Filipe Ferrari; Nelson Carvas Junior; Gabriel Carvalho; Santiago Alonso Tobar Leitão; Lívia Adams Goldraich; Nadine Clausell; Ricardo Stein Journal: BMJ Open Date: 2020-12-29 Impact factor: 3.006