Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

October 31, 2018 updated by: Dr. Soetomo General Hospital

The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients

The purpose of the study is investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Majority of chronic heart failure patients became intolerance of physical training that could limit activity. Recent studies reported that Neuromuscular electrical stimulation (NMES) application could increase muscle mass, oxidative enzyme, endothelial function, VO2 peak and quality of life in chronic heart failure patient. It was hypothesized that Neuromuscular Electrical Stimulation (NMES) assisted muscle contraction in chronic heart failure patients will increase the activity of myokine (Interleukin-6 and Interleukin-15), that in turn will promote exercise tolerance in this patient. the aim of this study was to investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol. Thirty chronic heart failure patients in cardiology ward that fulfilled inclusion criteria were randomized in two groups; the control group (standard inpatient cardiac rehabilitation protocol) and the intervention group (standard inpatient cardiac rehabilitation protocol and NMES). The intervention was done every day for seven days. Measurement of serum IL-6 and IL-15 were done before and after study, and analyzed by sandwich immunoassay with monoclonal antibody.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60285
        • Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • heart failure patients admitted to the hospital NYHA II-III
  • no weakness of lower limbs
  • stable hemodynamic, already received standard treatment based on patient condition
  • able to follow instruction
  • lived at Surabaya or Sidoarjo
  • assigned the informed consent

Exclusion Criteria:

  • knee osteoarthritis with knee pain that interfere the ambulation
  • phlebitis and active bleeding on lower limb
  • use vasoactive drug (such as Dobutamin etc)
  • already receive NMES before at femoris area in last 6 weeks before admission
  • fracture of lower limb that interfere the ambulation
  • sensory deficit at lower limb
  • acute infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
standard protocol for cardiac rehabilitation
EXPERIMENTAL: Intervention group
standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)
Device: Neuromuscular electrical stimulation (NMES)
NMES was placed on the quadriceps muscle of both legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6 and IL-15
Time Frame: before and 7th day of treatment
pg/ml
before and 7th day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soetomo General Hospital

Investigators

  • Principal Investigator: Hening Laswati, Dr, Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2017

Primary Completion (ACTUAL)

March 29, 2017

Study Completion (ACTUAL)

March 29, 2017

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/Panke.KKE/I/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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