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. 2018 Dec 21;2018(12):CD012678. doi: 10.1002/14651858.CD012678.pub2

Aamann 2018.

Methods Randomised, outpatient, open, parallel‐arm trial
Participants 39 participants with cirrhosis. Baseline data for 39 participants (intervention 20; control 19)
Participant characteristics (mean ± standard deviation or %)
  • Age: intervention 61.7 ± 7.8; control 63.0 ± 7.0 years

  • Men: intervention 80%; control 80%

  • Child‐Pugh A/B/C: intervention 50%/50%/0%; control 52.6%/47.4%/0%

  • Model of End‐Stage Liver Disease score: intervention 10.8 ± 2.7; control 10.7 ± 2.8

  • Body mass index: intervention 26.9 ± 3.0; control 25 ± 4.2 kg/m2


Aetiology
  • Alcohol: intervention 80%; control 78.9%

  • Chronic hepatitis C: intervention 5%; control 10.5%

  • NASH: intervention 5%; control 0%

Interventions Intervention: 60‐minute sessions of resistance training. A Masters student of Sport Science and a physician supervised all sessions.
Control: no intervention.
Cointervention: standard protein diet (1.2–1.5 g/kg/day). All participants received advice from a dietician and filled out a protein diary.
Duration: 12 weeks
Outcomes Mortality, adverse events (serious and non‐serious), 6MWT, QoL, blood test, and nutritional status
Country Denmark
Inclusion period January 2015 to October 2017
Publication status Full‐paper article (in submission)
Notes The lead author of this review is the primary investigator of the trial; 2 review authors who were not involved in the trial (LG and AR) undertook the bias assessment of this trial.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Sequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open trial without blinding of participants or personnel
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open trial without blinding of all outcome assessments (blinded assessment of bioimpedance, anthropometric measurements, QoL, blood samples, 6MWT)
Incomplete outcome data (attrition bias) 
 All outcomes High risk 5 participants were lost to follow‐up (1 exercise; 2 controls; 2 controls died). Only participants who completed were included the analysis according to group allocation.
Selective reporting (reporting bias) Low risk Clinically relevant outcomes were defined and described. Primary outcomes listed in the trial registration (in ClinicalTrials.gov) corresponded to the outcomes listed in the unpublished paper (available to the review authors).
For‐profit funding Low risk No for‐profit funding
Other bias Low risk No other biases identified
Overall risk of bias assessment (non‐mortality outcomes) High risk High risk of bias
Overall risk of bias assessment (mortality) Low risk Low risk of bias