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Researchers asked if breathing HH would allow patients to perform a greater intensity of exercise and improve the benefits of a pulmonary rehabilitation program. Note: The Question asked in a research project may have the possible answers: "yes" and "no" as in this study, or may be a numerical result. The preconceived answer by the researchers to the question is called the hypothesis. The authors hypothesized that breathing HH would improve exercise tolerance, peak oxygen consumption (VO2 peak) and health related quality of life(HRQOL).
Methods
All patients signed an informed consent that had institutional ethics review board approval. Patients with COPD having a post bronchodilator FEV1/FVC less than 0.7 and FEV1 less than 80 percent predicted and who were exacerbation-free for greater than one month prior to study entry were recruited from the Caritas Centre for Lung Health in Edmonton, Canada.
The study was a prospective, two-armed, randomized controlled trial. Prospective means deriving new data on patients during the study rather than looking back over existing data in charts. Two-armed means two different therapies will be compared. Randomized means that each patient will be enrolled in one of the treatment arms by chance.
Eligible patients were randomized to either rehabilitation breathing HH (60 percent He and 40 percent 02) or breathing ambient air. The designated gas was supplied from covered gas cylinders into a 100-L nondiffusing bag that was attached to the ceiling above the cycle ergometer. The patients breathed from the bag via large-bore tubing through a low-resistance non-rebreathing mask that was sealed tightly to avoid the entrainment of room air. Patients were asked not to talk during or for a short period following exercise due to the change in vocal tone with helium.
All aerobic training was performed on a magnetically braked cycle ergometer. During each session, heart rate, blood pressure and exertional symptoms were monitored, Oxyhemoglobin saturation was monitored by a respiratory therapist blind to the study.
Pulmonary rehabilitation consisted of 90 minutes of exercise and 60 minutes of education classes, three days per week for six weeks. Differences between groups were compared using t tests, while changes within a group were compared using paired t tests with p < 0.05 as significant.
Results
Patients were enrolled between March 2005 and November 2006. There were 441 patients who were referred to rehabilitation. Only 38 of the 441 patients were enrolled with 19 in the HH group and 19 in the ambient air group. Of these, 31 completed pulmonary rehabilitation, 16 in the HH group and 15 in the ambient air group. Although pulmonary function did not change significantly in either group following rehabilitation, breathing HH increased V02 peak by 16 [ or -] 12 percent (p< 0.001). The HH group improved in all areas of the HRQOL, while only total and symptom scores were improved in the ambient air group (p<0.05).
Discussion/Reflections/Future Research
In their discussion, the authors noted that their study was the first to investigate the effect of breathing HH during pulmonary rehabilitation in patients with COPD without hypoxemia. This proof-of-concept study supported the hypothesis that HH can augment the known benefits of a comprehensive pulmonary rehabilitation program.
Methods
All patients signed an informed consent that had institutional ethics review board approval. Patients with COPD having a post bronchodilator FEV1/FVC less than 0.7 and FEV1 less than 80 percent predicted and who were exacerbation-free for greater than one month prior to study entry were recruited from the Caritas Centre for Lung Health in Edmonton, Canada.
The study was a prospective, two-armed, randomized controlled trial. Prospective means deriving new data on patients during the study rather than looking back over existing data in charts. Two-armed means two different therapies will be compared. Randomized means that each patient will be enrolled in one of the treatment arms by chance.
Eligible patients were randomized to either rehabilitation breathing HH (60 percent He and 40 percent 02) or breathing ambient air. The designated gas was supplied from covered gas cylinders into a 100-L nondiffusing bag that was attached to the ceiling above the cycle ergometer. The patients breathed from the bag via large-bore tubing through a low-resistance non-rebreathing mask that was sealed tightly to avoid the entrainment of room air. Patients were asked not to talk during or for a short period following exercise due to the change in vocal tone with helium.
All aerobic training was performed on a magnetically braked cycle ergometer. During each session, heart rate, blood pressure and exertional symptoms were monitored, Oxyhemoglobin saturation was monitored by a respiratory therapist blind to the study.
Pulmonary rehabilitation consisted of 90 minutes of exercise and 60 minutes of education classes, three days per week for six weeks. Differences between groups were compared using t tests, while changes within a group were compared using paired t tests with p < 0.05 as significant.
Results
Patients were enrolled between March 2005 and November 2006. There were 441 patients who were referred to rehabilitation. Only 38 of the 441 patients were enrolled with 19 in the HH group and 19 in the ambient air group. Of these, 31 completed pulmonary rehabilitation, 16 in the HH group and 15 in the ambient air group. Although pulmonary function did not change significantly in either group following rehabilitation, breathing HH increased V02 peak by 16 [ or -] 12 percent (p< 0.001). The HH group improved in all areas of the HRQOL, while only total and symptom scores were improved in the ambient air group (p<0.05).
Discussion/Reflections/Future Research
In their discussion, the authors noted that their study was the first to investigate the effect of breathing HH during pulmonary rehabilitation in patients with COPD without hypoxemia. This proof-of-concept study supported the hypothesis that HH can augment the known benefits of a comprehensive pulmonary rehabilitation program.
