NCT03728075

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 24, 2018

Last Update Submit

October 31, 2018

Conditions

Chronic Heart Failure

Keywords

NMESIL-6IL-15Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • IL-6 and IL-15

    pg/ml

    before and 7th day of treatment

Study Arms (2)

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

Neuromuscular electrical stimulation (NMES)DEVICE

NMES was placed on the quadriceps muscle of both legs

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital

Surabaya, East Java, 60285, Indonesia

Location

Study Officials

  • Hening Laswati, Dr

    Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 1, 2018

Study Start

January 21, 2017

Primary Completion

March 29, 2017

Study Completion

March 29, 2017

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

ID(1)