Trial Outcomes & Findings for The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD (NCT NCT02099799)

NCT ID: NCT02099799

Last Updated: 2021-09-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-09-05

Participant Flow

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.

51 not randomized (38 ineligible and 13 withdrew)

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pedometer and Internet Website n=75 Participants 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	Usual Care n=78 Participants 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 n=153 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 7.2 • n=113 Participants	70.4 years STANDARD_DEVIATION 7.3 • n=163 Participants	69.3 years STANDARD_DEVIATION 7.3 • n=160 Participants
Sex: Female, Male Female	5 Participants n=113 Participants	6 Participants n=163 Participants	11 Participants n=160 Participants
Sex: Female, Male Male	70 Participants n=113 Participants	72 Participants n=163 Participants	142 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	1 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	6 Participants n=113 Participants	8 Participants n=163 Participants	14 Participants n=160 Participants
Race (NIH/OMB) White	69 Participants n=113 Participants	69 Participants n=163 Participants	138 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
6-Minute Walk Test Distance	360.8 meters STANDARD_DEVIATION 92.0 • n=113 Participants	357.2 meters STANDARD_DEVIATION 103.5 • n=163 Participants	359 meters STANDARD_DEVIATION 97.7 • n=160 Participants
FEV1 percent predicted	60.6 percent STANDARD_DEVIATION 23.1 • n=113 Participants	61.5 percent STANDARD_DEVIATION 19.8 • n=163 Participants	61.1 percent STANDARD_DEVIATION 21.4 • n=160 Participants
Daily Step Count	3242 steps per day STANDARD_DEVIATION 2177 • n=113 Participants	3320 steps per day STANDARD_DEVIATION 2278 • n=163 Participants	3281 steps per day STANDARD_DEVIATION 2222 • n=160 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Pedometer and Internet Website n=75 Participants 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	Usual Care n=78 Participants 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
6-Minute Walk Test Distance	25 meters Standard Error 10	37 meters Standard Error 10

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pedometer and Internet Website n=75 Participants 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	Usual Care n=78 Participants 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
Health-related Quality of Life	-13.0 score on a scale Standard Error 3.6	-15.1 score on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pedometer and Internet Website n=75 Participants 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	Usual Care n=78 Participants 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
Dyspnea	-0.1 score on a scale Standard Error 0.2	0.0 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 6 months

Assessed by daily step counts on pedometer.

Change at 6 months compared to baseline.

Outcome measures

Measure	Pedometer and Internet Website n=75 Participants 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	Usual Care n=78 Participants 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
Engagement in Physical Activity	673 steps per day Standard Error 392	-639 steps per day Standard Error 415

SECONDARY outcome

Timeframe: 6 months

RAGE-receptor of advanced glycation end-products

Outcome measures

Measure	Pedometer and Internet Website n=49 Participants 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	Usual Care n=39 Participants 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
Inflammatory Biomarker Number 1	95.0 pg/mL Standard Deviation 319	22.0 pg/mL Standard Deviation 243

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide)

Outcome measures

Measure	Pedometer and Internet Website n=49 Participants 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	Usual Care n=39 Participants 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
Inflammatory Biomarker Number 2	57.1 pg/mL Standard Deviation 498	69.2 pg/mL Standard Deviation 314

Adverse Events

Pedometer and Internet Website

Serious events: 24 serious events

Other events: 36 other events

Deaths: 1 deaths

Usual Care

Serious events: 25 serious events

Other events: 25 other events

Deaths: 1 deaths

Serious adverse events

Measure	Pedometer and Internet Website n=75 participants at risk 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	Usual Care n=78 participants at risk 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
Respiratory, thoracic and mediastinal disorders Hospitalizations	30.7% 23/75 • Number of events 23 • 6 months 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.	30.8% 24/78 • Number of events 24 • 6 months 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.
Blood and lymphatic system disorders Death	1.3% 1/75 • Number of events 1 • 6 months 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.	1.3% 1/78 • Number of events 1 • 6 months 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.

Other adverse events

Measure	Pedometer and Internet Website n=75 participants at risk 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	Usual Care n=78 participants at risk 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
Musculoskeletal and connective tissue disorders Musculoskeletal adverse event	48.0% 36/75 • Number of events 36 • 6 months 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.	32.1% 25/78 • Number of events 25 • 6 months 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.

Additional Information

Marilyn Moy, MD, MSc

VA Boston Healthcare System

Phone: 857-203-6622

Email: marilyn.moy@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place