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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02099799
• Collaborator: (none)
• Enrollment: 153
• Locations: 2
• Arms: 2
• Actual Duration (Months): 50.7
• Patients Per Site: 76.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Emphysema; Chronic Bronchitis	Behavioral: Pedometer and Website	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Research assistant who assesses outcomes is blinded to randomization group.
• Primary Purpose: Treatment
• Official Title: The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
• Actual Study Start Date: Nov 17, 2015
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Feb 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pedometer and Internet Website Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.	Behavioral: Pedometer and Website; Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
No Intervention: Usual Care Verbal instructions and written materials about exercise.

Outcome Measures

Primary Outcome Measures

1. 6-Minute Walk Test Distance [6 months]

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

Secondary Outcome Measures

1. Health-related Quality of Life [6 months]

   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

2. Dyspnea [6 months]

   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

3. Engagement in Physical Activity [6 months]

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

4. Inflammatory Biomarker Number 1 [6 months]

   RAGE-receptor of advanced glycation end-products

Other Outcome Measures

1. Inflammatory Biomarker Number 2 [6 months]

   Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama	United States	35233
2	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Marilyn L. Moy, MD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 21, 2019

More Information

Publications

• Danilack VA, Weston NA, Richardson CR, Mori DL, Moy ML. Reasons persons with COPD do not walk and relationship with daily step count. COPD. 2014 Jun;11(3):290-9. doi: 10.3109/15412555.2013.841670. Epub 2013 Oct 23.
• Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Chest. 2015 Jul;148(1):128-137. doi: 10.1378/chest.14-1466.
• Moy ML, Danilack VA, Weston NA, Garshick E. Daily step counts in a US cohort with COPD. Respir Med. 2012 Jul;106(7):962-9. doi: 10.1016/j.rmed.2012.03.016. Epub 2012 Apr 20.
• Moy ML, Garshick E, Matthess KR, Lew R, Reilly JJ. Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2008;45(4):611-7.
• Moy ML, Janney AW, Nguyen HQ, Matthess KR, Cohen M, Garshick E, Richardson CR. Use of pedometer and Internet-mediated walking program in patients with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2010;47(5):485-96.
• Moy ML, Matthess K, Stolzmann K, Reilly J, Garshick E. Free-living physical activity in COPD: assessment with accelerometer and activity checklist. J Rehabil Res Dev. 2009;46(2):277-86.
• Moy ML, Teylan M, Danilack VA, Gagnon DR, Garshick E. An index of daily step count and systemic inflammation predicts clinical outcomes in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Feb;11(2):149-57. doi: 10.1513/AnnalsATS.201307-243OC.
• Moy ML, Teylan M, Weston NA, Gagnon DR, Danilack VA, Garshick E. Daily step count is associated with plasma C-reactive protein and IL-6 in a US cohort with COPD. Chest. 2014 Mar 1;145(3):542-550. doi: 10.1378/chest.13-1052.
• Moy ML, Teylan M, Weston NA, Gagnon DR, Garshick E. Daily step count predicts acute exacerbations in a US cohort with COPD. PLoS One. 2013 Apr 4;8(4):e60400. doi: 10.1371/journal.pone.0060400. Print 2013.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02099799
• Other Study ID Numbers: O1150-R
• First Posted: Mar 31, 2014
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Physical Activity; COPD Self-Management; Internet; 6-Minute Walk Test; COPD Exacerbation; Health-related Quality of Life
• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Emphysema

Study Results

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 Detail	51 not randomized (38 ineligible and 13 withdrew)

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.	Verbal instructions and written materials about exercise.
Period Title: Overall Study
STARTED	75	78
COMPLETED	60	54
NOT COMPLETED	15	24

Baseline Characteristics

Arm/Group Title	Pedometer and Internet Website	Usual Care	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	75	78	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (7.2)	70.4 (7.3)	69.3 (7.3)
Sex: Female, Male (Count of Participants)
Female	5 6.7%	6 7.7%	11 7.2%
Male	70 93.3%	72 92.3%	142 92.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.3%	1 0.7%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 8%	8 10.3%	14 9.2%
White	69 92%	69 88.5%	138 90.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
6-Minute Walk Test Distance (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	360.8 (92.0)	357.2 (103.5)	359 (97.7)
FEV1 percent predicted (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	60.6 (23.1)	61.5 (19.8)	61.1 (21.4)
Daily Step Count (steps per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [steps per day]	3242 (2177)	3320 (2278)	3281 (2222)

Outcome Measures

1. Primary Outcome

Title	6-Minute Walk Test Distance
Description	In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	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	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
Measure Participants	75	78
Mean (Standard Error) [meters]	25 (10)	37 (10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.189
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Health-related Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	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	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
Measure Participants	75	78
Mean (Standard Error) [score on a scale]	-13.0 (3.6)	-15.1 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.572
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Dyspnea
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	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	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
Measure Participants	75	78
Mean (Standard Error) [score on a scale]	-0.1 (0.2)	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.799
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Engagement in Physical Activity
Description	Assessed by daily step counts on pedometer. Change at 6 months compared to baseline.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	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	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
Measure Participants	75	78
Mean (Standard Error) [steps per day]	673 (392)	-639 (415)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1312
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Inflammatory Biomarker Number 1
Description	RAGE-receptor of advanced glycation end-products
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	Pedometer and website with feedback, goal setting, educational and motivational content, and community forum. Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.	Verbal instructions and written materials about exercise.
Measure Participants	49	39
Mean (Standard Deviation) [pg/mL]	95.0 (319)	22.0 (243)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2265
	Comments
	Method	t-test, 2 sided
	Comments

6. Other Pre-specified Outcome

Title	Inflammatory Biomarker Number 2
Description	Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pedometer and Internet Website	Usual Care
Arm/Group Description	Pedometer and website with feedback, goal setting, educational and motivational content, and community forum. Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.	Verbal instructions and written materials about exercise.
Measure Participants	49	39
Mean (Standard Deviation) [pg/mL]	57.1 (498)	69.2 (314)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pedometer and Internet Website, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8897
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Significant, pulmonary, and musculoskeletal adverse events were tracked during the study. Significant adverse events were defined as deaths and/or hospitalizations. Pulmonary adverse events were self-reported at 3 and 6 months and included diagnoses of pneumonia and/or acute exacerbation of COPD. Musculoskeletal events were self-reported as chest, leg, foot and/or back pain or discomfort. Serious adverse events were defined as deaths and/or hospitalizations.
Arm/Group Title	Pedometer and Internet Website		Usual Care
Arm/Group Description	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		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
All Cause Mortality
	Pedometer and Internet Website		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/75 (1.3%)		1/78 (1.3%)
Serious Adverse Events
	Pedometer and Internet Website		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/75 (32%)		25/78 (32.1%)
Blood and lymphatic system disorders
Death	1/75 (1.3%)	1	1/78 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Hospitalizations	23/75 (30.7%)	23	24/78 (30.8%)	24
Other (Not Including Serious) Adverse Events
	Pedometer and Internet Website		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/75 (48%)		25/78 (32.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal adverse event	36/75 (48%)	36	25/78 (32.1%)	25

Limitations/Caveats

Strengths include the randomized study design, dual-site approach, and 6-month time frame. While the study expanded our past work with a more socioeconomically diverse sample, our cohort was self-selected and majority male, limiting generalizability.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.