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Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

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ClinicalTrials.gov Identifier: NCT03728075
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Soetomo General Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Neuromuscular electrical stimulation (NMES) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients
Actual Study Start Date : January 21, 2017
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : March 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. IL-6 and IL-15 [ Time Frame: before and 7th day of treatment ]
    pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728075


Locations
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Indonesia
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital
Surabaya, East Java, Indonesia, 60285
Sponsors and Collaborators
Dr. Soetomo General Hospital
Investigators
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Principal Investigator: Hening Laswati, Dr Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital

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Responsible Party: Dr. Soetomo General Hospital
ClinicalTrials.gov Identifier: NCT03728075     History of Changes
Other Study ID Numbers: 26/Panke.KKE/I/2017
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Soetomo General Hospital:
NMES
IL-6
IL-15
Chronic Heart Failure

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases