Andreozzi 2008.
Study characteristics | ||
Methods | Randomized placebo‐controlled trial | |
Participants | 44 male participants (22 intervention, 22 control) with intermittent claudication, admitted to the day hospital of the clinic of the authors. Half of the participants suffered from severe claudication (MWD < 100 m) and half had moderate claudication (MWD < 200 m), resulting in 4 equal subgroups of 11 participants each, based on intervention/control and severity of claudication | |
Interventions | Intervention: physical training 3 times weekly for 6 weeks + intravenous saline solution + intravenous 600 mg propionyl‐L‐carnitine 3 times weekly during the last 3 weeks of training Control: physical training 3 times weekly for 6 weeks + intravenous saline solution 3 times weekly during the last 3 weeks of training |
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Outcomes | Absolute claudication distance (= maximal walking distance) on treadmill (speed 2.5 km/h, slope 15%). Measurements were performed at baseline and after 3 and 6 weeks | |
Notes | Disease specific: rather short study duration Study authors did not receive any funding |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information about sequence generation of parallel groups |
Allocation concealment (selection bias) | Unclear risk | No description of the method of concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information about blinding available; double‐blind character assumed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information to permit judgement of "low risk" or "high risk" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All results for groups and subgroups are reported; all P values are calculated. No withdrawals from the study reported. Results for the whole population (severe + moderate) were requested and were received from the study author |
Selective reporting (reporting bias) | Low risk | Extensive reporting on ACD; probably no reporting bias |
Other bias | Unclear risk | Disease specific: rather short study duration |