Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-21

Study Completion Date

2017-03-29

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

standard protocol for cardiac rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation (NMES)

Intervention Type DEVICE

NMES was placed on the quadriceps muscle of both legs

Interventions

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Neuromuscular electrical stimulation (NMES)

NMES was placed on the quadriceps muscle of both legs

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No