NCT03201198: ActiveCOPD

Active for Life: Chronic Obstructive Pulmonary Disease

Completed NA Results posted Last updated 17 April 2024

What this trial tests

NA trial testing Active Life in Chronic Obstructive Pulmonary Disease in 182 participants. Completed in 31 January 2023.

Timeline

27 July 2017

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	182
Start date	27 July 2017
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Active Life
• Chair exercises

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

University of Michigan

Who can join

50 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor Primary · 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)

The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)

Baseline-T1

Group	Value	95% CI
Active Life	278	± 144
Chair Exercises	269	± 138

T2

Group	Value	95% CI
Active Life	293	± 138
Chair Exercises	285	± 130

T3

Group	Value	95% CI
Active Life	293	± 156
Chair Exercises	279	± 138

T4

Group	Value	95% CI
Active Life	282	± 154
Chair Exercises	257	± 99

T5

Group	Value	95% CI
Active Life	277	± 145
Chair Exercises	299	± 146

Time Spent in Sedentary Behavior Primary · 7 days of continuous activity monitoring at each interval

The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)

Baseline (T1)

Group	Value	95% CI
Active Life	683	± 180
Chair Exercises	698	± 187

T2

Group	Value	95% CI
Active Life	661	± 173
Chair Exercises	658	± 177

T3

Group	Value	95% CI
Active Life	661	± 180
Chair Exercises	672	± 180

T4

Group	Value	95% CI
Active Life	683	± 182
Chair Exercises	681	± 160

T5

Group	Value	95% CI
Active Life	671	± 174
Chair Exercises	639	± 169

Six-minute Walk Test Secondary · Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention

This is the maximal distance a subject can walk during six minutes.

Baseline (T1)

Group	Value	95% CI
Active Life	1241	± 306
Chair Exercises	1202	± 324

T2

Group	Value	95% CI
Active Life	1368	± 254
Chair Exercises	1234	± 339

T3

Group	Value	95% CI
Active Life	1320	± 343
Chair Exercises	1281	± 295

T4

Group	Value	95% CI
Active Life	1339	± 280
Chair Exercises	1272	± 294

T5

Group	Value	95% CI
Active Life	1311	± 267
Chair Exercises	1264	± 307

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 months for each subject enrolled who completed the entire study period. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Life

Serious: 7/82 (9%)

Deaths: 4/82

Chair Exercises

Serious: 5/84 (6%)

Deaths: 1/84

Serious adverse events (1 terms)

Reaction	System	Active Life	Chair Exercises
acute exacerbation requiring hospitalization	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Active Life	Chair Exercises
Fall with non-serious injury	Injury, poisoning and procedural complications	—	—
Exercise intolerance due to pain or injury, non-serious	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: acute exacerbation requiring hospitalization.

Data from ClinicalTrials.gov NCT03201198 adverse events section.

Sponsor's own description

This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical activity and improve the health of people with chronic obstructive pulmonary disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD).
   Burge AT, Cox NS, Abramson MJ, Holland AE. · · 2020 · cited 87× · PMID 32297320 · DOI 10.1002/14651858.cd012626.pub2