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. 2021 May 7;2021(5):CD010876. doi: 10.1002/14651858.CD010876.pub3

Pressler 2016.

Study characteristics
Methods Study design: randomised controlled pilot trial
No of centres: 3
Country: Germany
Dates patients recruited: October 2012 to April 2014
When randomised: 83 ± 34 days (range 42 to 132) after intervention
Maximum follow‐up (from baseline): 24 ± 6 months
Participants Inclusion criteria: TAVI within previous 6 months, physically able and clinically stable to perform regular exercise as judged by study investigators, optimal medical treatment for cardiac and concomitant diseases, written informed consent. Only patients living within a reasonable distance from the exercise centre were contacted and were consecutively included in the screening process
Exclusion criteria: patients' decision to undergo TAVI despite receiving a recommendation for SAVR by the heart team (to avoid inclusion of atypical, low‐risk TAVI patients), physical disabilities making regular exercise impossible, unstable cardiac conditions (e.g. decompensated heart failure, New York Heart Association (NYHA) Class IV, severe rhythm disorders), uncontrolled hypertension or diabetes, severe obstructive pulmonary disease (forced expiratory volume in 1 second b50%). Patients were not included in cases of echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus mean transaortic pressure gradient ≥ 20 mmHg, or velocity ≥ 3 m/s, at least moderate paravalvular regurgitation, signs of ischaemia, severe arrhythmias, or haemodynamic deterioration during the initial exercise test)
N Randomised: total: 30;intervention: 13;comparator: 14
 
Diagnosis (% of pts)
e.g.
Aetiology: (total): aortic regurgitation (TG = 53%, UC = 73%), coronary artery disease (TG = 69%, UC = 71%), previous myocardial infarction (TG = 15%, UC = 35%), coronary artery bypass graft (TG = 23%, UC = 14%), atrial fibrillation (TG = 54%, UC = 36%), pacemaker/ICD (TG = 15%, UC = 21%), previous cerebrovascular event (TG = 8%, UC = 21%)
NYHA: TG: Class I: 1 (8), Class II: 10 (77), Class III: 2 (15); UC: Class I: 4 (29), Class II: 6 (42), Class III: 4 (29)
LVEF: TG: 58 ± 8%; UC: 57 ± 10%
Case mix: NR
Age (mean ± SD): total: 81 ± 6; intervention: 81 ± 7;comparator: 81 ± 5
Percentage male: 15/30 (50%):intervention: 47% (N = 7/15);comparator: 53% (8/15)
 
Ethnicity: NR
Interventions Intervention (exercise‐based CR)
Description: the training group received combined endurance and resistance exercise starting with 2 exercise sessions during the first week, followed by 3 sessions per week during Weeks 2 to 8. Resistance training started in Week 2 and was conducted subsequent to the endurance exercise portion in 2 of the 3 weekly workouts
Time of start after event: 81 days ± 27 days post TAVI in the exercise group;
84 days ± 41 days post TAVI in the usual care group
Components: exercise
Detail of exercise: exercise consisted of endurance training on cycle ergometers at moderate intensities, starting with 20 minutes and gradually increasing to 45 minutes by Week 8. Resistance training occurred after endurance training twice weekly from Week 2
Modality: cycle 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): NR
Length of session: 20 to 45 minutes/session
Frequency/no. of sessions: Week 1: 2/week; Weeks 2 to 8: 2 to 3/week
Intensity : 45% to 70% VO2 peak
Resistance training included: yes + muscular endurance (bench press, rowing, shoulder press, pull‐down, leg press) 1 to 3 sets at 50% to 60% 1 RM
Total duration: 8 weeks
Setting: hospital
Supervision: Supervised
Intermittent nurse or exercise specialist support? NR
Co‐interventions: NR
Comparator
Description: usual care. Not receiving structured exercise
Co‐interventions: both groups received usual medical care
Outcomes Outcomes (scale measured in): exercise tolerance assessed by cardiopulmonary testing (VO2 peak), exercise capacity (6‐minute walk distance), HRQoL (KCCQ and SF‐12), mortality, all‐cause or cardiovascular
Other outcomes measured
Muscular strength with 1 repetition maximum testing, prosthetic aortic valve function with echocardiography
Notes Follow‐up: baseline, 8 weeks after baseline visit, 24 ± 6 months after baseline
This study received grant support from the German Heart Foundation/German Foundation of Heart Research (Frankfurt, Germany; F/14/12). Author BL received financial support from the German Cardiac Society (Düsseldorf, Germany) via the Otto‐Hess‐Research‐Grant
Conflict of interest: none declared
There were 3 dropouts: 2 from the training group that were unrelated to the intervention (1 had an accident, 1 had a lethal cerebral haemorrhage) and 1 from the usual care group who was not willing to continue in the study