Long-Term Effects of Pedometer-Based Physical Activity Coaching in Severe COPD: A Randomized Controlled Trial

Dario Kohlbrenner, Noriane A Sievi, Oliver Senn, Malcolm Kohler, Christian F Clarenbach, Dario Kohlbrenner, Noriane A Sievi, Oliver Senn, Malcolm Kohler, Christian F Clarenbach

Abstract

Background and objective: Limited evidence on long-term effects of physical activity programs in COPD is available. The aim of the study was to investigate the effects of a three-month program combining physical activity counselling and pedometer-based feedback in addition to usual care, followed by a nine-month unsupervised observation period as compared to usual care in participants with severe to very severe COPD.

Methods: Participants were randomized to either a control group receiving usual care or an intervention group receiving motivational support, an activity diary with an individual step count goal (ie, an increase of ≥15% from baseline) and a pedometer in addition to usual care. The intervention ended after three months and an unsupervised observational period followed until twelve months. Primary outcome was daily step count after one year.

Results: Seventy-four participants were included, 61 (82%) completed the study. Linear regression modelling, adjusted for baseline step count, showed no significant difference in change in step count after 12 months between the groups (Β = 547.33, 95% CI = -243.55/1338.20).

Conclusion: A three-month program combining physical activity counselling and pedometer-based feedback in addition to usual care does not attenuate the declining course of physical activity in participants with severe and very severe COPD during a long term follow-up of one year as compared to usual care. This result was primarily determined by the low intervention response rates to the combined program.

Clinical trial registration: www.ClinicalTrials.gov, NCT03114241.

Keywords: COPD; counselling program; long-term follow-up; physical activity; randomized controlled trial.

Conflict of interest statement

M. Kohler reports personal fees from Bayer, Astra Zeneca, Boehringer Ingelheim, Novartis, Roche, CSL Behring, and Mundipharma, outside the submitted work. M. Kohler is member of the board of the Deep Breath Initiative (DBI). A company that provides services in the field of breath analysis C.F. Clarenbach reports personal fees from Roche, Novartis, Boehringer Ingelheim, GSK, Astra Zeneca, Sanofi, Vifor, and Mundipharma, outside the submitted work. The authors report no other potential conflicts of interest for this work.

© 2020 Kohlbrenner et al.

Figures

Figure 1
Figure 1
Study participant flow diagram.
Figure 2
Figure 2
Boxplots showing daily step count at baseline and 3- and 12-month follow-up visits in control group (difference from baseline to end of study −108 (1057) steps) and intervention group (−480 (1703) steps), p = 0.342. Data are mean (SD). Solid grey line: mean.
Figure 3
Figure 3
Boxplots showing the changes in daily step count compared to baseline values at 3- and 12-month follow-ups stratified according to group allocation.
Figure 4
Figure 4
Boxplots showing daily step count at baseline and 3- and 12-month follow-up visits in participants increasing their PA ≥ 15% (difference from baseline to end of study 303 (1170) steps) and participants increasing their PA

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