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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

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 1, 2018
Actual Study Start Date  ICMJE January 21, 2017
Actual Primary Completion Date March 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
IL-6 and IL-15 [ Time Frame: before and 7th day of treatment ]
pg/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient
Official Title  ICMJE The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Heart Failure
Intervention  ICMJE Device: Neuromuscular electrical stimulation (NMES)
NMES was placed on the quadriceps muscle of both legs
Study Arms  ICMJE
  • No Intervention: Control group
    standard protocol for cardiac rehabilitation
  • Experimental: Intervention group
    standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)
    Intervention: Device: Neuromuscular electrical stimulation (NMES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 29, 2017
Actual Primary Completion Date March 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728075
Other Study ID Numbers  ICMJE 26/Panke.KKE/I/2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Soetomo General Hospital
Study Sponsor  ICMJE Dr. Soetomo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hening Laswati, Dr Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital
PRS Account Dr. Soetomo General Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP