Giavedoni 2012.
Methods | Randomised controlled trial in which 1 leg received electrical stimulation and 1 leg received no stimulation. The choice of leg to receive stimulation was randomised. | |
Participants | 11 participants were enrolled and all completed the study (5 men, mean FEV1 % predicted = 41 (SEM 6) %, mean age = 72 (SEM 3) yr). They were recruited within 48 hours of admission to hospital with an acute exacerbation of COPD. | |
Interventions | Intervention: electrical stimulation of the quadriceps of 1 leg using an asymmetric, biphase pulse wave at a frequency of 50 Hz, pulse width of 400 ms for 30 minutes per day, once per day for 14 days. Duty cycle was 8 s on, 20 s off. Intensity was set at the maximum that could be tolerated for each participant. 4 sessions were supervised (3 in hospital and 1 at home) with the rest performed unsupervised either in hospital or at home (after discharge). Adherence was optimised with 2 telephone calls following discharge and extra supervised sessions were offered if needed. Control: no stimulation |
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Outcomes | BMI (descriptive data only) Airflow obstruction via spirometry (descriptive data only) Quadriceps strength was measured as force generated during a maximum isometric voluntary contraction using a strain gauge |
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Notes | Study supported by the BLF. Investigator supported by ERS long‐term research fellowship | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "…the dominant leg was randomly allocated to treatment with NMES or no stimulation (control)." 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 | 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 | Unclear risk | Insufficient details on attrition to comment on whether this was a source of bias. |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Low risk | Study appeared free from other sources of bias. |