Methods
Subjects and study design
Forty-two patients who were diagnosed with stable COPD
from mild to very severe stage (GOLD) [13] were enrolled in
the present study. The patients were all retired. The inclusion
criteria for this study were: (1) the patient was in
stable condition with no infection or exacerbation of COPD
for at least the prior 3 months; (2) the patient was able to
walk unassisted and operate the device to measure their PA;
(3) the patient had no severe and/or unstable cardiac disease,
orthopedic disease, or mental disorder that could
impair physical activities in daily life. The objective and
content of the study were orally explained to the participants,
with additional documents. Written consent was obtained
after all patients were informed that they could
decide whether or not to participate based on their own free
will and that their privacy would be sufficiently considered.
The trial design was a prospective, randomized,
controlled trial (Fig. 1). The patients were randomly
assigned to one of two groups: the PR (pulmonary rehabilitation
only) or PR þ P (Pulmonary rehabilitation and feedback
from using a pedometer) group. Patients were not
blinded to the randomization. This study followed the COPD
patients from baseline before the PR to 1 year later. The
assessments of physical activity in daily life, pulmonary
function, submaximal exercise capacity (6MWD; six-minute
walk distance), respiratory and quadriceps muscle force,
functional status, and health-related quality of life were
done at baseline before the PR and 1 year from the baseline.
This study was reviewed and approved by the Ethics
Committees of our hospital and the Akita University Graduate
School of Medicine, and carried out in conformity with
the Declaration of Helsinki, 2008