NCT02786849

Brief Summary

The objective of this study will be to evaluate the effects of neuromuscular electrical stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on peripheral muscle strength, exercise capacity and muscle change and inflammation markers in patients with chronic kidney disease (CKD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

May 5, 2016

Last Update Submit

September 21, 2016

Conditions

Kidney DiseasesChronic Kidney DiseasesChronic Kidney InsufficiencyChronic Renal InsufficiencyChronic Renal DiseasesRenal DialysisHemodialysis

Keywords

Electric StimulationElectric Stimulation Therapy

Outcome Measures

Primary Outcomes (2)

  • Peripheral muscle strength

    Increased quadriceps strength evaluated by the Isokinetic Biodex System 4 Pro in isometric mode. The highest peak extensor torque is recorded.

    one month

  • Six-minute walk test

    It will be used to evaluate submaximal exercise capacity and will be held in accordance with the recommendations of the American Thoracic Society (Holland et al, 2014.). The larger distance between the two tests will be used for the analysis, this being compared to pre and after training. The reference values are those described by Britto et al., 2013 and an increase of 25 meters after the training will be considered a clinically important improvement.

    one month

Secondary Outcomes (9)

  • Pulmonary function test

    one month

  • Quality of life

    one month

  • Anxiety and Depression

    one month

  • urea clearance

    one month

  • glomerular filtration rate

    one month

  • +4 more secondary outcomes

Study Arms (2)

Group of high frequency and intensity

EXPERIMENTAL

Group realized high frequency and intensity neuromuscular electrical stimulation

Other: neuromuscular electrical stimulation of high frequency and intensity

Group of low frequency and intensity

EXPERIMENTAL

Group realized neuromuscular electrical stimulation of low frequency and intensity

Other: neuromuscular electrical stimulation of low frequency and intensity

Interventions

neuromuscular electrical stimulation of high frequency and intensityOTHER

Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis. Will be applied using portable stimulators with 4 channels. The parameters are: frequency of 50 Hz, pulse width 400ms, rise time and 2s descent, stimulus mode on-off starting with a ratio of 1: 2 in the first week (stimulus time of 10 seconds and rest time of 20s, aiming at adaptation and mitigation of the effects of muscle fatigue), evolving from the second week to a ratio of 1:1 (stimulation time of 10 seconds and rest time of 10s). The current intensity is adjusted individually for the first application and gradually increased as the tolerance of patients. In each session there will be a warm-up period, training and slowdown. The intensity will be the maximum tolerated by the patient in order increments every session, this being monitored for further evolutionary calculating.

Group of high frequency and intensity
neuromuscular electrical stimulation of low frequency and intensityOTHER

Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis. Will be applied using portable stimulators with 4 channels. The parameters are: 5 Hz frequency, time on: off 1: 3 with a pulse duration of 100ms. The current intensity is adjusted individually for the first application and it was the least noticeable by the patient. In each session there will be a warm-up period, training and slowdown.

Group of low frequency and intensity

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CKD diagnostic who are on dialysis regularly for at least 6 months, stable and under medical supervision.
  • Patients without uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
  • Patients without diseases that limit the electrical stimulation protocol (respiratory, orthopedic and / or neurological).
  • Patients who do not do any form of physical training or who have been held for more than six months.

You may not qualify if:

  • Inability to perform any of the study assessments (lack of understanding or collaboration).
  • Recent decompensation of the clinical picture with or without hospitalization.
  • Presence of chronic obstructive pulmonary disease (COPD or emphysema), musculoskeletal diseases that impede the realization of assessments and training protocol.
  • Uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
  • Abnormal sensitivity in the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Karla Vieira Brüggemann

Santo Amaro da Imperatriz, SC - Santa Catarina, 88140-000, Brazil

RECRUITING

Related Publications (1)

  • Bruggemann AK, Mello CL, Dal Pont T, Hizume Kunzler D, Martins DF, Bobinski F, Pereira Yamaguti W, Paulin E. Effects of Neuromuscular Electrical Stimulation During Hemodialysis on Peripheral Muscle Strength and Exercise Capacity: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):822-831.e1. doi: 10.1016/j.apmr.2016.12.009. Epub 2017 Jan 16.

    PMID: 28093194DERIVED

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2016

First Posted

June 1, 2016

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

BR(1)