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Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation (NMES)
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring NMES, IL-6, IL-15, Chronic Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

standard protocol for cardiac rehabilitation

standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)

Outcomes

Primary Outcome Measures

IL-6 and IL-15
pg/ml

Secondary Outcome Measures

Full Information

First Posted
October 24, 2018
Last Updated
October 31, 2018
Sponsor
Dr. Soetomo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03728075
Brief Title
Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient
Official Title
The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
March 29, 2017 (Actual)
Study Completion Date
March 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Soetomo General Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
NMES, IL-6, IL-15, Chronic Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
standard protocol for cardiac rehabilitation
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation (NMES)
Intervention Description
NMES was placed on the quadriceps muscle of both legs
Primary Outcome Measure Information:
Title
IL-6 and IL-15
Description
pg/ml
Time Frame
before and 7th day of treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hening Laswati, Dr
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60285
Country
Indonesia

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

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