Inspire: INSpiratory muscle training for Patients admitted to ICU and outcomes on Recovery: a pilot randomized controlled trial

Annually 70.000- 80.000 patients are admitted to the intensive care unit (ICU)
in the Netherlands. Medical treatment for critical illness such as sedation and
mechanical ventilation (MV) instigate pathophysiological processes associated
with poor long-term outcome and mortality. ICU-acquired muscle weakness,
impaired exercise capacity and fatigue are the most frequent physical
impairments among survivors of critical illness, which may last up to 5 years
after hospital discharge. Respiratory muscle weakness (RMW)- and specifically
diaphragm weakness-, can occur within 24 hours of MV and is associated with
failed weaning, prolonged ICU-stay, and mortality. Recent studies report
longitudinal associations between RMW at ICU- or hospital discharge and
decreased handgrip strength, exercise capacity and quality of life, confirming
the importance of early identification of RMW in survivors of critical illness.
While inspiratory muscle training (IMT) is recommended to facilitate weaning,
interventions are seldom continued after ICU and hospital discharge. Patients
experience symptoms of fatigue, shortness of breath, decreased muscle strength
and limited exercise capacity after ICU- and hospital discharge. These symptoms
may be part of the post-intensive care syndrome (PICS) and greatly affect the
perceived quality of life of these patients. Several studies have been done in
sports and in patients with COPD showing an association between respiratory
muscle training and physical capacity. The results suggest that IMT linear
represents an effective tool to improve the inspiratory muscle strength, as
well as physical performance performance and Quality of Life.
We hypothesize that continuing respiratory muscle training after ventilator
withdrawal could improve physical recovery after discharge from the hospital.

This pilot study aims to assess the feasibility of procedures for a future
randomised multicentre trial (RCT) on IMT effectiveness after weaning from MV
and to gather patient and physiotherapist experiences with IMT.

We will perform a pilot randomized controlled trial.
Patients will be included when they meet the criteria and be distributed to the
intervention or control group. Each group consists of 15 participants.
Participants in the intervention group get an individual IMT program, 5 days a
week, for the duration of 6 weeks. Training will be monitored by a well-trained
physiotherapist and participants are asked to keep a daily record about their
experiences.
All participants, intervention and control, will be measured weekly, as long as
the patient is in the hospital. After discharge, measurements are done 6 weeks,
3 months and 6 months after inclusion.

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

- (Partial) paralyse of the diafragm
- Incapable of performing assignments (RASS -3, -4, -5, +2, +3, +4)
- Severe neurological disease or brain injury
- patients with a contraindication to IMT (pneumothorax, air leakage through
chest drain)
- insufficient command of the dutch language

There is low risk for adverse events or negative side effects. Patients may
experience (increased) feelings of tightness or fatigue as a result of the
breathing muscle training.