The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of global morbidity and is
projected to become the third leading cause of death in the world by 2020. In Veterans, the
prevalence is high; in VISN1 in FY 2012, 9% of outpatient Veterans had the ICD-9 diagnosis of
COPD. In COPD, shortness of breath leads to physical inactivity and significant disability. A
growing body of knowledge has identified physical activity and exercise as a modifiable
factor that may impact COPD-related morbidity and mortality. Epidemiological and
cross-sectional studies have shown that persons with COPD who are more physically active have
better functional status and are less likely to be hospitalized and to die. A higher daily
step count, when directly measured, is associated with lower risk of acute exacerbations
(AEs) and mortality in COPD, independent of lung function. Despite the potential benefits,
there have been few interventions to increase walking in persons with COPD. Although
supervised pulmonary rehabilitation programs improve exercise capacity, they are not
accessible to all who could benefit from them and have low adherence rates.

Novel interventions that incorporate strategies for behavioral change and that are
accessible, individualized, and sustained are needed to promote physical activity in persons
limited by COPD. Funded by a RR&D CDA-2 Dr. Moy and her team have developed and piloted a
novel exercise intervention that combines a website with a pedometer to promote walking in
persons with COPD. The program, Every Step Counts (ESC) for Lung Health, accurately monitors
walking, provides iterative feedback and individualized goal-setting, and delivers education
and motivation.

This study proposes a 2-arm randomized, controlled trial to study the efficacy of ESC to
improve exercise capacity in persons with COPD, compared to usual care (verbal and written
instructions to exercise).

Primary Aim: Determine the efficacy of the ESC intervention to increase 6-minute walk test
(6MWT) distance.

Secondary Aims: Estimate the effect of the ESC intervention on (a) health-related quality of
life (HRQL), as measured by the St. George's Respiratory Questionnaire (SGRQ), (b) dyspnea,
(c) inflammatory biomarkers C-reactive protein (CRP) and interleukin-6 (IL-6), (d) risk for
AEs and COPD-related hospitalizations, and (e) engagement in physical activity as measured by
daily step count.

185 subjects will be enrolled for a total of 12 months, with the interventional phase being 6
months followed by an observational phase of 6 months. Subjects will be randomized (1:1
ratio) to one of 2 arms: (1) verbal and written instructions to exercise at home (usual care)
or (2) usual care plus pedometer and Internet-mediated walking program. Subjects will perform
6MWTs, complete questionnaires, and have blood drawn at clinic visits at baseline, 3, 6, and
12 months. Telephone contact will occur at 9 months. AE history and daily step count will be
assessed at each contact. Analysis of variance will compare 6MWT distance in the intervention
and usual care group at 6 months. Multivariate regression models will assess 6MWT distance as
a function of treatment group, adjusting for baseline 6MWT distance, study site, season of
enrollment, and any unbalanced baseline characteristics.

This study hypothesizes that persons randomized to ESC will have greater 6MWT distance at 6
months, compared to persons in the usual care group. It also hypothesize that persons
randomized to ESC will have greater improvements in HRQL, dyspnea, daily step counts, and
greater decreases in levels of inflammatory biomarker and risk for AEs and COPD-related
hospitalizations, compared to control.

The proposed intervention has the potential to (1) bring an exercise program to the vast
majority of persons with COPD who cannot go to a hospital-based pulmonary rehabilitation
program, (2) improve the effectiveness of current rehabilitation programs by sustaining
long-term exercise, and (3) become an effective and integral part of COPD self-management
programs. Ultimately, the intervention could decrease risk of hospitalizations, AEs, and
COPD-related morbidity and mortality.

Inclusion Criteria:

- Male and female subjects, greater than or equal to 40 years of age

- Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity
< 0.70 or chest CT evidence of emphysema. CT obtained as part of routine clinical
care, independent of research study.

- Medical clearance from healthcare provider to participate in an exercise program

- Have an active email account and can check email at least weekly

- Have access to a computer with Internet connection or willing to come to VABoston or
Birmingham VA Medical Center to use study computers

- Pedometer with >90% accuracy compared to manual counts on short clinic walk

- Competent to provide informed consent

- Willingness to make return visits and be available by telephone for duration of study

Exclusion Criteria:

- COPD exacerbation in the previous 1 month

- Unable to ambulate with or without assistance

- Clinical signs of unstable cardiovascular disease or congestive heart failure

- Hypoxemia during 6MWT, i.e. oxygen saturation <85% using supplemental oxygen

- Unable to complete questionnaires

- Unable to collect at least 5 of 7 days of baseline step counts

- Participation in a pulmonary rehabilitation program at time of screening or within the
previous 3 months

- Participation in another exercise-related research study at time of screening

- Plans to participate in an exercise-related research study in the next 6 months

- Plans to enroll in a supervised exercise program, such as pulmonary rehabilitation, in
the next 6 months