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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03788876
Other study ID # 20180497
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 3, 2019
Est. completion date November 1, 2020

Study information

Verified date June 2020
Source Hospital de Clinicas de Porto Alegre
Contact Graciele Sbruzzi
Phone +555133085857
Email graciele.sbruzzi@ufrgs.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Skin lesions at the electrode placement points.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neuromuscular electrical stimulation
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 care
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.

Locations

Country Name City State
Brazil HCPA Porto Alegre Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). three weeks
Primary 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). three weeks
Secondary 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. three weeks
Secondary Dynamometry Dynamometry = handgrip test three weeks
Secondary 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. three weeks
Secondary 30 meter walk test Evaluates walking speed for six minutes three weeks
Secondary Spirometry Evaluates lung function three weeks
Secondary Blood Markers Evaluates markers of muscle injury. three weeks
Secondary Hydric balance Through patient records three weeks
Secondary length of stay in the ICU Through patient records three weeks
Secondary Length of stay in invasive mechanical ventilation Through patient records three weeks
Secondary Time of weaning from invasive mechanical ventilation Through patient records three weeks
Secondary Survival Rate Through patient records three weeks
Secondary Success of weaning from invasive mechanical ventilation Through patient records three weeks
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