Chronic Respiratory FailureNCT01930643
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
A study testing EMS in people with Chronic Respiratory Failure and Critical Illness Myopathy, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Respiratory Failure, Critical Illness Myopathy
- What is being tested?
- EMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient required mechanical ventilation more than 14 days
- No ability for active endurance exercise because of poor consciousness or limb weakness.
Who cannot join
- Pregnant women
- Limb wound/infection interfered with electric pad application
- Recent acute myocardial infarction or life-threatening arrhythmia
- Uncontrolled epilepsy
- Dying patients without attempt of ventilator weaning
- Absence of respiratory drive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.
Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.
Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.
Read the detailed description
Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).
EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).
- Being tested
- EMS
- Keywords
- Electric muscle stimulation, mechanical ventilation, chronic respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMSDevice
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Electric muscle stimulation(EMS) | Experimental | EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week. Receives: Device: EMS |
| Control | No intervention | Patients with routine passive rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free Days
the cumulative ventilator-free days after intervention, in following 28 days.
Measured: 28 days
Secondary outcomes (1)
Grip Power
Weekly improvement of both hand grip muscle power in kilogram(Kg)
Measured: 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start21 Aug 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: slow recruitment and change of faculty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Respiratory 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuang-Hua Cheng, MD, Mackay Memorial Hospital
- Investigators
- Kuang H Cheng, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930643
- Sponsor's protocol ID
- 13MMHIS070
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2013
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01930643
- Acronym / sponsor ID
- 13MMHIS070
- Keywords
- Electric muscle stimulation, mechanical ventilation, chronic respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment and change of faculty
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 21 Aug 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.
Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.
Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.
Detailed description
Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).
EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric muscle stimulation(EMS) | Experimental | Device: EMSEMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week. |
| Control | No intervention | –Patients with routine passive rehabilitation program. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient required mechanical ventilation more than 14 days
- No ability for active endurance exercise because of poor consciousness or limb weakness.
Key exclusion criteria (6 listed)
- Pregnant women
- Limb wound/infection interfered with electric pad application
- Recent acute myocardial infarction or life-threatening arrhythmia
- Uncontrolled epilepsy
- Dying patients without attempt of ventilator weaning
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 |
|---|---|---|
| EMSHELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. | Device | Electric muscle stimulation(EMS) |
Primary outcome
Ventilator-free Days
Time frame: 28 days
the cumulative ventilator-free days after intervention, in following 28 days.
1 secondary outcome
Grip Power
Time frame: 7 days after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kuang H Cheng, MD principal investigator
Mackay Memorial 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 EMS in people with Chronic Respiratory Failure and Critical Illness Myopathy, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Jul 2019. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ventilator-free Days (time frame: 28 days). 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 8 Jul 2019.