Exercise Training in Severe COPD
Condition: COPD
Study type: Interventional

Summary: 
      International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate
      COPD patients looking at the work setting, programs and frequency of training sessions in an
      outpatient program of rehabilitation. However, a new population of respiratory patients is
      growing: these are more serious and older patients, with several comorbidities and recurrent
      hospitalizations. In this population no guidelines are available to describe the optimum
      prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In
      this kind of patients, only few studies are available on the overtraining risk. The aims of
      the current study are:

        1. To detect and compare the response in terms of endurance of two endurance training
           programs with different time-frequencies (1 session / day versus 2 sessions / day)
           during 30 days of in-hospital admission to a pulmonary rehabilitation center

        2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and
           respiratory muscle strength, quality of life and psychological and functional impact of
           the disease.
    

Detailed description: 
      Rehabilitation in-hospital program

      The rehabilitation program (RP) will start the day after the in-hospital admission and will
      be continuously supervised by a physiotherapist. The patients will use the drugs and the
      oxygen therapy prescribed. RP will include a training session on cycloergometer at constant
      load once a day (Group F1) or twice-a day (Group F2) interrupted by at least three hours of
      rest. The workout will start with a workload of 50% of the theoretical maximum Watts
      indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al.

      Measures

      At baseline (T0) we will gather in both groups the following evaluations:

        1. Anthropometric parameters (age, BMI)

        2. Scale of comorbidity CIRS

      At the baseline (T0) and end of the program (T1) we will collect, in all patients, the
      following evaluations:

        1. 6-minute walking test walk (6MWT) will be performed according to international
           guidelines. In patients using oxygen during walking, the oxygen flow will be adjusted to
           increase the oxygen saturation over 96%.The 6MWT at T1 will be performed with the same
           amount of oxygen used in the initial test (T0).

        2. Endurance cycloergometer test will be performed at 80% of Watts max predicted by the
           6MWT. At the beginning, the test will be performed at charge "zero watts" for 2 minutes,
           then the workload will be increased to 80% of the theoretical max Watts until muscle
           exhaustion (Borg score > 8), presence of high dyspnea (Borg score > 8) or the
           achievement of 90% of theoretical maximal heart rate. The final endurance test will be
           repeated at the same load (speed 50-60 rpm). The time spent for performing the exercise
           will be registered. In a subset of patients (belonging to the Institute of Lumezzane)
           the endurance cycloergometer test on the quadriceps muscle will be executed by the Near
           Infrared Spectroscopy (NIRS ).

        3. Scale of the MRC dyspnea

        4. Arterial blood gas analysis

        5. Respiratory muscle strength (Maximal lnspiratory Pressure [MIP] and Maximal Espiratory
           Pressure [MEP])

        6. Biceps and quadriceps muscle strength evaluated with dynamometer manual

        7. CAT scale

      Only at the end of the program (T1) we will collect:

        1. patient satisfaction by a Likert scale taking into consideration the quantity, quality,
           and impact of rehabilitation on hospitalization

        2. The time consuming for the two programs

        3. The side effect

        4. The drop out (waste, flare)
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load.
At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each < 5 ).
The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; training; endurance