Fondazione Salvatore Maugeri
Lumezzane, Brescia, 25065, Italy
NCT Number: NCT02522637
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.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Lumezzane, Brescia, 25065, Italy
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:
At the baseline (T0) and end of the program (T1) we will collect, in all patients, the following evaluations:
Only at the end of the program (T1) we will collect:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%.
Time frame: 30 days
Evaluation of the time needing for the test execution
Fondazione Salvatore Maugeri
Other
What is the Best Frequency of Exercise Training in Severe COPD?
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