Neuromuscular Electrical Stimulation in Chronic Heart Fai... | NCT03728075

Studies
Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

NCT03728075

Sponsor

Dr. Soetomo General Hospital

Status

Completed

Last Update Posted

Nov 1, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Chronic Heart Failure

Interventions

Neuromuscular electrical stimulation (NMES)

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2017Actual

Primary Completion Date

Mar 29, 2017Actual

Completion Date

Mar 29, 2017Actual

First Submitted Date

Oct 24, 2018

First Submission Date that Met QC Criteria

Oct 31, 2018

First Posted Date

Nov 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2018

Last Update Posted Date

Nov 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention	standard protocol for cardiac rehabilitation
Intervention group	Experimental	standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)	Device: Neuromuscular electrical stimulation (NMES)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuromuscular electrical stimulation (NMES)	Device	NMES was placed on the quadriceps muscle of both legs	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hening Laswati, Dr	Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital		Surabaya	East Java	60285	Indonesia