Clinical trial NCT03728075: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: NMES
IL-6
IL-15
Chronic Heart Failure
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: IL-6 and IL-15
timeFrame: before and 7th day of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital
state: East Java
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital
name: Hening Laswati, Dr
role: PRINCIPAL_INVESTIGATOR
References: