Kucio 2016.
Methods | Randomised controlled trial | |
Participants | 30 hospitalised participants were enrolled (21 men). All participants entered a traditional pulmonary rehabilitation programme for 3 weeks. 15 were allocated to the intervention group (11 men, mean FEV1 = 1.66 (SD 0.69) L, mean age = 68 (SD 6) yr). 15 were allocated to the control group (10 men, mean FEV1 = 1.78 (SD 0.78) L, mean age = 61 (SD 8) yr). | |
Interventions | Participants in both groups received pulmonary rehabilitation (3 weeks, 6 supervised sessions per week that comprised breathing exercises, treadmill walking and resistance exercise). Intervention: NMES of the quadriceps and gastrocnemius using symmetric rectangular impulses with pulse width of 0.30 ms at a frequency of 35 Hz for 2 s on and 4 s off for 36 min. Details of stimulation duration and intensity were not provided. Control: no stimulation |
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Outcomes | Exercise capacity via the 6MWT Airflow obstruction via spirometry Arterial oxygen and carbon dioxide concentrations via arterialised capillary samples |
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Notes | Funding support not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients that fulfilled the inclusion criteria were randomly assigned to one of the two groups." Details pertaining to the development of the randomisation sequence were not reported. |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No sham stimulation. Neither participants nor investigators administering the intervention were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding for outcome assessors. This may have affected their outcome related to muscle strength. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the 30 participants randomised, 2 withdrew from the control group |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | High risk | Disproportionate number of men |