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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02099799
Acronym
WEB
Enrollment
153
Registered
2014-03-31
Start date
2015-11-17
Completion date
2020-02-07
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Bronchitis, COPD, Emphysema

Keywords

Physical Activity, COPD Self-Management, Internet, 6-Minute Walk Test, COPD Exacerbation, Health-related Quality of Life

Brief summary

COPD currently afflicts 24 million US residents; the prevalence of COPD is high among Veterans. Persons with COPD have significant functional disability as a result of the disease. This project will determine whether a novel Internet-mediated walking program coupled with a pedometer can improve exercise capacity, improve health-related quality of life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise intervention could help over 8 million persons. The Veterans Health Administration (VHA) has a strong commitment to providing care to persons with COPD and supporting research directed at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and Development includes research in COPD rehabilitation. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.

Detailed description

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.

Interventions

BEHAVIORALPedometer and Website

Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Research assistant who assesses outcomes is blinded to randomization group.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6-Minute Walk Test Distance6 monthsIn-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.

Secondary

MeasureTime frameDescription
Health-related Quality of Life6 monthsQuestionnaires that assess quality of life. St. George's Respiratory Questionnaire Total Score Scores range 0-100 Higher score reflects worse HRQL. Change at 6 months compared to baseline
Dyspnea6 monthsAssessed by questionnaire that measure breathlessness and shortness of breath. mMRC dyspnea score Scores range 0-4. Higher values reflect more shortness of breath. Change at 6 months compared to baseline
Engagement in Physical Activity6 monthsAssessed by daily step counts on pedometer. Change at 6 months compared to baseline.
Inflammatory Biomarker Number 16 monthsRAGE-receptor of advanced glycation end-products

Other

MeasureTime frameDescription
Inflammatory Biomarker Number 26 monthsInflammatory protein biomarker NT-proBNP (beta natriuretic peptide)

Countries

United States

Participant flow

Recruitment details

Participants were enrolled from Nov 2015-Nov 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR). 204 consented (143 BOS and 61 BIR); 51 not randomized (38 ineligible and 13 withdrew); 153 randomized (108 BOS and 45 BIR); 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR); 15 Lost to follow-up at 6 months (8 BOS and 7 BIR); 74 included in the analyses.

Pre-assignment details

51 not randomized (38 ineligible and 13 withdrew)

Participants by arm

ArmCount
Pedometer and Internet Website
Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR). 204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR) 15 Lost to follow-up at 6 months (8 BOS and 7 BIR) 74 included in the analyses
75
Usual Care
Verbal instructions and written materials about exercise. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR). 204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 78 allocated to Pedometer and Internet Website Arm (54 BOS and 24 BIR) 24 Lost to follow-up at 6 months (13 BOS and 11 BIR) 78 included in the analyses
78
Total153

Baseline characteristics

CharacteristicPedometer and Internet WebsiteTotalUsual Care
6-Minute Walk Test Distance360.8 meters
STANDARD_DEVIATION 92
359 meters
STANDARD_DEVIATION 97.7
357.2 meters
STANDARD_DEVIATION 103.5
Age, Continuous69.2 years
STANDARD_DEVIATION 7.2
69.3 years
STANDARD_DEVIATION 7.3
70.4 years
STANDARD_DEVIATION 7.3
Daily Step Count3242 steps per day
STANDARD_DEVIATION 2177
3281 steps per day
STANDARD_DEVIATION 2222
3320 steps per day
STANDARD_DEVIATION 2278
FEV1 percent predicted60.6 percent
STANDARD_DEVIATION 23.1
61.1 percent
STANDARD_DEVIATION 21.4
61.5 percent
STANDARD_DEVIATION 19.8
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants14 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
69 Participants138 Participants69 Participants
Sex: Female, Male
Female
5 Participants11 Participants6 Participants
Sex: Female, Male
Male
70 Participants142 Participants72 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 751 / 78
other
Total, other adverse events
36 / 7525 / 78
serious
Total, serious adverse events
24 / 7525 / 78

Outcome results

Primary

6-Minute Walk Test Distance

In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet Website6-Minute Walk Test Distance25 metersStandard Error 10
Usual Care6-Minute Walk Test Distance37 metersStandard Error 10
p-value: 0.189Mixed Models Analysis
Secondary

Dyspnea

Assessed by questionnaire that measure breathlessness and shortness of breath. mMRC dyspnea score Scores range 0-4. Higher values reflect more shortness of breath. Change at 6 months compared to baseline

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet WebsiteDyspnea-0.1 score on a scaleStandard Error 0.2
Usual CareDyspnea0.0 score on a scaleStandard Error 0.2
p-value: 0.799Mixed Models Analysis
Secondary

Engagement in Physical Activity

Assessed by daily step counts on pedometer. Change at 6 months compared to baseline.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet WebsiteEngagement in Physical Activity673 steps per dayStandard Error 392
Usual CareEngagement in Physical Activity-639 steps per dayStandard Error 415
p-value: <0.001Mixed Models Analysis
Secondary

Health-related Quality of Life

Questionnaires that assess quality of life. St. George's Respiratory Questionnaire Total Score Scores range 0-100 Higher score reflects worse HRQL. Change at 6 months compared to baseline

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet WebsiteHealth-related Quality of Life-13.0 score on a scaleStandard Error 3.6
Usual CareHealth-related Quality of Life-15.1 score on a scaleStandard Error 3.2
p-value: 0.572Mixed Models Analysis
Secondary

Inflammatory Biomarker Number 1

RAGE-receptor of advanced glycation end-products

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet WebsiteInflammatory Biomarker Number 195.0 pg/mLStandard Deviation 319
Usual CareInflammatory Biomarker Number 122.0 pg/mLStandard Deviation 243
p-value: 0.2265t-test, 2 sided
Other Pre-specified

Inflammatory Biomarker Number 2

Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide)

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Pedometer and Internet WebsiteInflammatory Biomarker Number 257.1 pg/mLStandard Deviation 498
Usual CareInflammatory Biomarker Number 269.2 pg/mLStandard Deviation 314
p-value: 0.8897t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026