Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

Dr. Soetomo General Hospital

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: Neuromuscular electrical stimulation (NMES)

Study type: Interventional

Funder types: Other

Identifiers

NCT03728075

26/Panke.KKE/I/2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control group

No Intervention group

Description:

standard protocol for cardiac rehabilitation

Intervention group

Experimental group

Description:

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

Treatment:

Device: Neuromuscular electrical stimulation (NMES)