Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge
Condition: COVID-19 Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID
      after hospital discharge. Muscle deconditioning, dysautonomia, and exercise hyperventilation
      have been proposed as potential mechanisms contributing to exercise functional capacity
      limitation in Long-COVID. Along this line, combined exercise training or inspiratory muscle
      training (IMT) alone have already been demonstrated to be feasible therapeutic options for
      Long-COVID patients. However, we do not have evidence about the effects of a home-based IMT
      program for 12-week on peak oxygen consumption (peakVO2). in patients chronic COVID (>3
      months) after hospital discharge.

      This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard
      management alone or combined with a program of IMT that will be carried out in a single
      center. After randomization, patients will be clinically evaluated. The primary endpoint
      (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients
      with chronic COVID (>3 months) after hospital discharge will be enrolled. A sample size
      estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean
      peakVO2: +3 mL/kg/min (SD±2.5)] of 26 patients (13 per arm) would be necessary to test our
      hypothesis.
    

Detailed description: 
      Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID
      after hospital discharge. Muscle deconditioning, dysautonomia, and exercise hyperventilation
      have been proposed as potential mechanisms contributing to exercise functional capacity
      limitation in Long-COVID. Along this line, combined exercise training or inspiratory muscle
      training (IMT) alone have already been demonstrated to be feasible therapeutic options for
      Long-COVID patients. However, we do not have evidence about the effects of a home-based IMT
      program for 12-week on peak oxygen consumption (peakVO2). in patients chronic COVID (>3
      months) after hospital discharge.

      This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard
      management alone or combined with a program of IMT that will be carried out in a single
      center. Patients allocated to the IMT arm will be instructed to train at home twice daily,
      for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc.,
      Parsippany, NJ). They will be instructed by a physiotherapist responsible for training
      intervention and educated to maintain diaphragmatic breathing during the training period. The
      subjects will start breathing at a resistance equal to 25% to 30% of their maximal
      inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the
      patients at weekly intervals by checking the diary card and measuring the MIP each time. The
      resistance will be modified each session according to the 25% to 30% of their MIP measured.
      After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2)
      will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients with chronic
      COVID (>3 months) after hospital discharge will be enrolled. A sample size estimation [alfa:
      0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +3 mL/kg/min
      (SD±2.5)] of 26 patients (13 per arm) would be necessary to test our hypothesis.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Behavioral
Intervention description(s): Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment