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 %)
Aetiology
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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 |
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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 Primary outcomes listed in the trial registration (in ClinicalTrials.gov) corresponded to the outcomes listed in the unpublished paper (available to the review authors).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 |