Effects of electrical stimulation and ventilatory muscle training in patients with kidney disease on hemodialysis

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-25tcrt
• Date of registration: 01/05/2012
• Primary sponsor: Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA - Porto Alegre, RS, Brazil
• Public title: Effects of electrical stimulation and ventilatory muscle training in patients with kidney disease on hemodialysis
• Scientific title: Effects of functional electrical stimulation and inspiratory muscle training on quality of life and functional capacity of patients with end-stage renal disease on hemodialysis: a randomized clinical trial
• Date of first enrolment: 10/03/2011
• Target sample size: 60
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-25tcrt/
• Study design: Clinical trial, 4 groups, open, randomized controlled

Countries of recruitment

Brazil

Contacts

• Name: Thiago Dipp
• Affiliation: Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

• Name: Rodrigo Plentz
• Affiliation: Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

Key inclusion & exclusion criteria

Inclusion criteria: Patients with ESRD undergoing hemodialysis more than 3 months; Urea clearance during hemodialysis (Kt / V) > 1.2
Exclusion criteria: Patients with recent stroke, disabling osteoarticular or musculoskeletal disease, uncontrolled hypertension (SBP > 230mmHg and DBP > 120 mmHg), heart failure class III or IV according to the NYHA or decompensated, uncontrolled diabetes (glicaemia > 300 mg / dL), unstable angina, fever and / or infectious disease, acute respiratory failure; recent acute myocardial infarction (2 months), active smoking


Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

End-stage renal disease
C12.777.419.780.750
E02.870.300

Intervention(s)

Functional Electrical Stimulation (n=15): FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. Extensor knee muscle will be stimulated.

Inspiratory muscle training (n=15): IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure

Functional electrical stimulation associated with inspiratory muscle training (FES + IMT n=15): will be held for 12 weeks, the EEF will be performed at first hour of haemodialysis and TMI in the patient's home.

Control (n=15): without intervention

Primary Outcome(s)

Functional capacity assessed by distance walked in 6-Minute Walk Test

Quality of life assessed by the questionnaire for kidney disease "Kidney Disease and Quality of Life - Short Form"

Secondary Outcome(s)

Autonomic control by frequency counter

Hand-grip strength by dynamometry

Lung function measured by spirometry

Oxidative stress

Percentage of body fat by skinfold

Peripheral muscle resistance assessed by the number of repetitions in Sit-to-Stand test

Respiratory muscle strength assessed by manometer

Secondary ID(s)

Irmandade da Santa Casa de Misericórdia de Porto Alegre

SISNEP

Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

Source(s) of Monetary Support

Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA - Porto Alegre, RS, Brazil

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasília, DF, Brazil

Secondary Sponsor(s)

Irmandade da Santa Casa de Misericórdia de Porto Alegre - Porto Alegre, RS, Brazil