Lung TransplantationNCT03788876
Neuromuscular Electrical Stimulation After Lung Transplantation
A study testing Neuromuscular electrical stimulation and Conventional care in people with Lung Transplantation and Electric Stimulation, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Electric Stimulation, Clinical Trial
- What is being tested?
- Neuromuscular electrical stimulation and Conventional care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 May 2019to 1 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral and Unilateral lung transplant;
- After extubation of invasive mechanical ventilation up to 48 hours for stable patients;
- After extubation of invasive mechanical ventilation up to 72 hours for those who are present in the instability;
- Chronic obstructive pulmonary disease
- Cystic fibrosis
- Fibrotic pulmonary idiopathic
Who cannot join
- Skin lesions at the electrode placement points.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
HCPA
Porto Alegre, Rio Grande do Sul, 90.035-903
Graciele Sbruzzi, doctor, +55 51 3359-7334 ext. (51) 3359-7334, gsbruzzi@hcpa.edu.br
Luma Zanatta de Oliveira, graduate, +55 51 998473359, lumazanatta@hotmail.com
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-072
Rodrigo Della Méa Plentz, Doctor, roplentz@yahoo.com.br
Isadora Rebolho Sisto, Graduate, isadora_sisto@hotmail.com
About this study
Official title: Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, Neuromuscular Electrical Stimulation (NMES) rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the Hospital of Clinics of Porto Alegre (HCPA) and Irmandade da Santa Casa de Misericórdia de Porto Alegre.
Read the detailed description
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, NMES rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the HCPA. The NMES training will be applied once a day (30 minutes of application per session, increasing one minute every two days and reducing the OFF time), until the discharge of the Intensive Care Unit (ICU). The patient will continue with the application also in the Hospitalization Units of the HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until the hospital discharge. The following outcomes will be evaluated: thickness and strength of the quadriceps muscle, pulmonary function, endothelial function, functional capacity, mobility, muscle biochemical markers, arterial blood gas analysis, water balance and length of stay in the ICU, time and success of weaning from invasive mechanical ventilation and survival rate through medical records analysis.
- Conditions
- Lung Transplantation, Electric Stimulation, Clinical Trial
- Being tested
- Neuromuscular electrical stimulation, Conventional care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
The NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge.
Conventional careOther
Physiotherapy protocol will be performed by HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation | Active comparator | The NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge and the protocol of physiotherapy by the physiotherapists of HCPA twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. Receives: Other: Neuromuscular electrical stimulation; Other: Conventional care |
| Conventional care | Sham comparator | The protocol of physiotherapy by the physiotherapists of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral quadriceps muscle thickness
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
Measured: three weeks
Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
Measured: three weeks
Secondary outcomes (12)
Muscle Strength - Scale Medical Research Council (MRC)
The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors, and shoulder abductors) and lower limbs (dorsal ankle flexors, knee extensors, and hip flexors). Each muscle group will be given a score between 0 (complete paralysis) and 5 (normal strength), and the total score can range from 0 to 60 points.
Measured: three weeks
Dynamometry
Dynamometry = handgrip test
Measured: three weeks
Sit and stand up
At the starting signal the subject will have to get up until standing and returning to a sitting position. The subject will be encouraged to perform 10 consecutive repetitions in the shortest possible time interval.
Measured: three weeks
30 meter walk test
Evaluates walking speed for six minutes
Measured: three weeks
Spirometry
Evaluates lung function
Measured: three weeks
Blood Markers
Evaluates markers of muscle injury.
Measured: three weeks
Hydric balance
Through patient records
Measured: three weeks
length of stay in the ICU
Through patient records
Measured: three weeks
Length of stay in invasive mechanical ventilation
Through patient records
Measured: three weeks
Time of weaning from invasive mechanical ventilation
Through patient records
Measured: three weeks
Survival Rate
Through patient records
Measured: three weeks
Success of weaning from invasive mechanical ventilation
Through patient records
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start3 May 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graciele Sbruzzi, Principal investigator, Hospital of Clinics of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788876
- Sponsor's protocol ID
- 20180497
- Status last verified
- Jun 2020
- First submitted
- 27 Nov 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03788876
- Acronym / sponsor ID
- 20180497
- Conditions
- Lung Transplantation, Electric Stimulation, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 28 Dec 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.
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, Neuromuscular Electrical Stimulation (NMES) rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the Hospital of Clinics of Porto Alegre (HCPA) and Irmandade da Santa Casa de Misericórdia de Porto Alegre.
Detailed description
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, NMES rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the HCPA. The NMES training will be applied once a day (30 minutes of application per session, increasing one minute every two days and reducing the OFF time), until the discharge of the Intensive Care Unit (ICU). The patient will continue with the application also in the Hospitalization Units of the HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until the hospital discharge. The following outcomes will be evaluated: thickness and strength of the quadriceps muscle, pulmonary function, endothelial function, functional capacity, mobility, muscle biochemical markers, arterial blood gas analysis, water balance and length of stay in the ICU, time and success of weaning from invasive mechanical ventilation and survival rate through medical records analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Active comparator | Other: Neuromuscular electrical stimulation, Other: Conventional careThe NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge and the protocol of physiotherapy by the physiotherapists of HCPA twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. |
| Conventional care | Sham comparator | Other: Conventional careThe protocol of physiotherapy by the physiotherapists of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bilateral and Unilateral lung transplant;
- After extubation of invasive mechanical ventilation up to 48 hours for stable patients;
- After extubation of invasive mechanical ventilation up to 72 hours for those who are present in the instability;
- Chronic obstructive pulmonary disease
- Cystic fibrosis
Key exclusion criteria (1 listed)
- Skin lesions at the electrode placement points.
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 stimulationThe NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge. | Other | Neuromuscular electrical stimulation |
| Conventional carePhysiotherapy protocol will be performed by HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises. | Other | Conventional care, Neuromuscular electrical stimulation |
Primary outcome
Femoral quadriceps muscle thickness
Time frame: three weeks
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
Time frame: three weeks
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
12 secondary outcomes
Muscle Strength - Scale Medical Research Council (MRC)
Time frame: three weeks
Dynamometry
Time frame: three weeks
Sit and stand up
Time frame: three weeks
30 meter walk test
Time frame: three weeks
Spirometry
Time frame: three weeks
Blood Markers
Time frame: three weeks
Hydric balance
Time frame: three weeks
length of stay in the ICU
Time frame: three weeks
Length of stay in invasive mechanical ventilation
Time frame: three weeks
Time of weaning from invasive mechanical ventilation
Time frame: three weeks
Survival Rate
Time frame: three weeks
Success of weaning from invasive mechanical ventilation
Time frame: three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
Graciele Sbruzzi principal investigator
Hospital of Clinics of Porto Alegre
2 sites 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 and Conventional care in people with Lung Transplantation and Electric Stimulation, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graciele Sbruzzi (+555133085857, graciele.sbruzzi@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral quadriceps muscle thickness (time frame: three weeks). The study lists 2 primary outcomes in all. 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 4 Jun 2020.