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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03728075
Other study ID # 26/Panke.KKE/I/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2017
Est. completion date March 29, 2017

Study information

Verified date October 2018
Source Dr. Soetomo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 29, 2017
Est. primary completion date March 29, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neuromuscular electrical stimulation (NMES)
NMES was placed on the quadriceps muscle of both legs

Locations

Country Name City State
Indonesia Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital Surabaya East Java

Sponsors (1)

Lead Sponsor Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary IL-6 and IL-15 pg/ml before and 7th day of treatment
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