Nilsson 2019.
Study characteristics | ||
Methods |
Study design: RCT No of centres: 1 Country: Sweden Dates patients recruited: August 2011 and December 2014 When randomised: after surgery Maximum follow‐up (from baseline): 1 year |
|
Participants |
Inclusion criteria: all adult patients undergoing AVR due to AS Exclusion criteria: any other concomitant cardiac disease, symptomatic lung disease, or mental or physical disability possibly limiting participation in the study N Randomised: total: 12;intervention: 6;comparator: 6 Diagnosis (% of pts): e.g. Aetiology: (total): HR at rest TG (50 to 93), UC (48 to 91); SBP at rest TG (110 to 145), UC (110 to 170); DBP at rest (mmHg) TG (60 to 90), UC (70 to 95) NYHA: NR LVEF: NR Case mix: NR Age (mean ± SD): total: 62.5 (39 to 75); intervention: 58.5 (39 to 75);comparator: 65.5 (60 to 71) Percentage male: total: 75%; intervention: 83.33%;comparator: 66.67% Ethnicity: NR |
|
Interventions |
Intervention (exercise‐based CR) Description: the exercise training protocol was designed according to the most recent European position paper concerning exercise training in cardiac patients in addition to feasibility over a large span of age and fitness. Heart rate, workload (Watts), and perceived exertion (Borg RPE scale) were recorded every 5 minutes, and the workload was adjusted to preserve HR within the given interval according to the protocol Time of start after event: 5 to 6 weeks postoperatively Components: aerobic exercise Detail of exercise: patients allocated to EX performed heart rate‐guided supervised exercise training on a bicycle ergometer Modality: bicycle ergometer Dose of exercise (calculated as overall no. of weeks of training multiplied by mean number of sessions per week multiplied by mean duration of sessions in minutes): 12 x 3 x 20 vigorous aerobic activity ± 12 x 5 x 30 light to moderate physical activity Length of session: not clearly stated but about 45 to 60 minutes Frequency/no. of sessions: 3 sessions per week Intensity: workload was adjusted to preserve HR within the given interval according to the protocol Resistance training included? NR Total duration: 12 weeks Setting: hospital Supervision: yes, heart rate‐guided supervised Intermittent nurse or exercise specialist support? NR Co‐interventions: NR Comparator Description: patients in CON received the same general physical activity recommendations as those in EX at discharge and were contacted on 3 occasions during the 12 weeks to encourage them to follow these recommendations and to give them the opportunity to ask any questions connected to recovery and physical activity Co‐interventions: NR |
|
Outcomes |
Outcomes (scale measured in): peak VO2 measured during maximal exercise test on a cycle ergometer using cardiopulmonary exercise testing with oxygen uptake Other outcomes measured Effect on submaximal cardiopulmonary variables including oxygen uptake kinetics (tau), oxygen uptake efficiency slope (OUES), and ventilatory efficiency (VE/VCO2 slope) |
|
Notes | Follow‐up: baseline (i.e. 5 to 6 weeks postoperatively), at the end of the 12‐week intervention (i.e. 3 months from baseline), and 1 year hereafter Study was supported by the Medical Research Council of Southeast Sweden (FORSS) and ALF Grants, Region Östergötland Study authors have no conflicts of interest |