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Feasibility and effects of intra-dialytic low-frequency electrical muscle stimulation and cycle training: a pilot randomized controlled trial
McGregor G, Ennis S, Powell R, Hamborg T, Raymond NT, Owen W, Aldridge N, Evans G, Goodby J, Hewins S, Banerjee P, Krishnan NS, Ting SMS, Zehnder D
PLoS ONE 2018 Jul;13(7):e0200354
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND AND OBJECTIVES: Exercise capacity is reduced in chronic kidney failure (CKF). Intra-dialytic cycling is beneficial, but comorbidity and fatigue can prevent this type of training. Low-frequency electrical muscle stimulation (LF-EMS) of the quadriceps and hamstrings elicits a cardiovascular training stimulus and may be a suitable alternative. The main objectives of this trial were to assess the feasibility and efficacy of intra-dialytic LF-EMS versus cycling. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Assessor blind, parallel group, randomized controlled pilot study with sixty-four stable patients on maintenance hemodialysis. Participants were randomized to 10 weeks of (1) intra-dialytic cycling, (2) intra-dialytic LF-EMS, or 3) non-exercise control. Exercise was performed for up to one hour three times per week. Cycling workload was set at 40 to 60% oxygen uptake (VO2) reserve, and LF-EMS at maximum tolerable intensity. The control group did not complete any intra-dialytic exercise. Feasibility of intra-dialytic LF-EMS and cycling was the primary outcome, assessed by monitoring recruitment, retention and tolerability. At baseline and 10 weeks, secondary outcomes including cardio-respiratory reserve, muscle strength, and cardio-arterial structure and function were assessed. RESULTS: Fifty-one (of 64 randomized) participants completed the study (LF-EMS 17 (77%), cycling 16 (80%), control 18 (82%)). Intra-dialytic LF-EMS and cycling were feasible and well tolerated (9% and 5% intolerance respectively, p = 0.9). At 10-weeks, cardio-respiratory reserve (VO2peak) (difference versus control LF-EMS +2.0 (95% CI 0.3 to 3.7) ml/kg/min, p = 0.02, and cycling +3.0 (95% CI 1.2 to 4.7) ml/kg/min, p = 0.001) and leg strength (difference versus control LF-EMS +94 (95% CI 35.6 to 152.3) N, p = 0.002 and cycling +65.1 (95% CI 6.4 to 123.8) N, p = 0.002) were improved. Arterial structure and function were unaffected. CONCLUSIONS: Ten weeks of intra-dialytic LF-EMS or cycling improved cardio-respiratory reserve and muscular strength. For patients who are unable or unwilling to cycle during dialysis, LF-EMS is a feasible alternative.

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