Chronic Heart FailureNCT03728075
Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient
A study testing Neuromuscular electrical stimulation (NMES) in people with Chronic Heart Failure, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Neuromuscular electrical stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jan 2017to 29 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga / Dr Soetomo General Hospital
Surabaya, East Java, 60285
About this study
Official title: The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients
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
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Neuromuscular electrical stimulation (NMES)
- Keywords
- NMES, IL-6, IL-15, Chronic Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
NMES was placed on the quadriceps muscle of both legs
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard protocol for cardiac rehabilitation |
| Intervention group | Experimental | standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) Receives: Device: Neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 and IL-15
pg/ml
Measured: before and 7th day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start21 Jan 2017
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hening Laswati, Dr, Principal investigator, Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728075
- Sponsor's protocol ID
- 26/Panke.KKE/I/2017
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03728075
- Acronym / sponsor ID
- 26/Panke.KKE/I/2017
- Conditions
- Chronic Heart Failure
- Keywords
- NMES, IL-6, IL-15, Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard protocol for cardiac rehabilitation |
| Intervention group | Experimental | Device: Neuromuscular electrical stimulation (NMES)standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation (NMES)NMES was placed on the quadriceps muscle of both legs | Device | Intervention group |
Primary outcome
IL-6 and IL-15
Time frame: before and 7th day of treatment
pg/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hening Laswati, Dr principal investigator
Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Airlangga/ Dr Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation (NMES) in people with Chronic Heart Failure, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 and IL-15 (time frame: before and 7th day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.