Effects of upper limbs' neuromuscular electrical stimulation (NMES) superimposed to voluntary contraction added to a protocol of intradialytic leg cycle ergometer exercise, in muscle strength, functional capacity and quality of life of adult patients with CKD: a randomized clinical trial protocol

Objective: To investigate the effects of unilateral upper limbs' (ULM) neuromuscular electrical stimulation (NMES) superimposed on a voluntary contraction added to a protocol of intradialytic leg cycle ergometer exercise on muscle strength, functional capacity and quality of life of adult patients with chronic kidney disease (CKD).

Methods: This randomized controlled clinical trial will be carried out at a Brazilian University Hospital. The patients will be evaluated and randomly allocated to an intervention group (i.e., unilateral NMES on the upper limb without hemodialysis fistula for 20 min and leg cycle ergometer for 30 min) or a control group (i.e., unilateral NMES-Sham on the upper limb without hemodialysis fistula for 20 min and leg cycle ergometer for 30 min). The patients will be treated for 8 weeks, with three weekly treatment sessions totaling 24 sessions.

Measurements: ULM muscle strength, functional capacity, quality of life and also the feasibility, safety and patient adherence to the exercise protocol. All physical measurements will be collected by trained researchers before treatment (week 0) and at the end of treatment (week 9), always in the second hemodialysis session of the week. It will be used in an intention-to-treat analysis.

Results/conclusions: The outcomes of this clinical trial protocol may help to know the possible benefits of unilateral ULM' NMES superimposed on a voluntary contraction added to a protocol of leg cycle ergometer for patients with CKD and to aid clinical decisions about future implementation or not of this technique (NMES) in intradialytic physical training programs.