The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial

Abstract Background Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physica...

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Main Authors: Crystian B. Oliveira, Márcia R. Franco, Chris G. Maher, Anne Tiedemann, Fernanda G. Silva, Tatiana M. Damato, Michael K. Nicholas, Diego G. D. Christofaro, Rafael Z. Pinto
Format: Article
Language:English
Published: BMC 2018-01-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-2436-z
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author Crystian B. Oliveira
Márcia R. Franco
Chris G. Maher
Anne Tiedemann
Fernanda G. Silva
Tatiana M. Damato
Michael K. Nicholas
Diego G. D. Christofaro
Rafael Z. Pinto
author_facet Crystian B. Oliveira
Márcia R. Franco
Chris G. Maher
Anne Tiedemann
Fernanda G. Silva
Tatiana M. Damato
Michael K. Nicholas
Diego G. D. Christofaro
Rafael Z. Pinto
author_sort Crystian B. Oliveira
collection DOAJ
description Abstract Background Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients’ behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP. Methods This study will be a two-group, single-blind, randomised controlled trial. One hundred and sixty adults with chronic, nonspecific LBP will be recruited. Participants allocated to both groups will receive a group exercise programme. In addition, the intervention group will receive health coaching sessions (i.e. assisting the participants to achieve their physical activity goals) and an activity monitor (i.e. Fitbit Flex). The participants allocated to the control group will receive sham health coaching (i.e. encouraged to talk about their LBP or other problems, but without any therapeutic advice from the physiotherapist) and a sham activity monitor. Outcome measures will be assessed at baseline and at 3, 6 and 12 months post randomisation. The primary outcomes will be physical activity, measured objectively with an accelerometer, as well as pain intensity and disability at 3 months post randomisation. Secondary outcomes will be physical activity, pain intensity and disability at 6 and 12 months post randomisation as well as other self-report measures of physical activity and sedentary behaviour, depression, quality of life, pain self-efficacy and weight-related outcomes at 3, 6, and 12 months post randomisation. Discussion This study is significant as it will be the first study to investigate whether a multimodal intervention designed to increase physical activity levels reduces pain and disability, and increases physical activity levels compared to a control intervention in patients with chronic LBP. Trial registration ClinicalTrials.gov, ID: NCT03200509 . Registered on 28 June 2017.
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spelling doaj.art-4ba7a9b8b25d4755b116490af32582fc2022-12-22T01:54:13ZengBMCTrials1745-62152018-01-0119111010.1186/s13063-017-2436-zThe efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trialCrystian B. Oliveira0Márcia R. Franco1Chris G. Maher2Anne Tiedemann3Fernanda G. Silva4Tatiana M. Damato5Michael K. Nicholas6Diego G. D. Christofaro7Rafael Z. Pinto8Department of Physical Therapy, Faculty of Science and Technology, Sao Paulo State University (UNESP)Department of Physical Therapy, Faculty of Science and Technology, Sao Paulo State University (UNESP)School of Public Health, Sydney Medical School, University of SydneySchool of Public Health, Sydney Medical School, University of SydneyDepartment of Physical Therapy, Faculty of Science and Technology, Sao Paulo State University (UNESP)Department of Physical Therapy, Faculty of Science and Technology, Sao Paulo State University (UNESP)Pain Management Research Institute, University of Sydney at Royal North Shore HospitalDepartament of Physical Education, Faculty of Science and Technology, Sao Paulo State University (UNESP)Department of Physical Therapy, Faculty of Science and Technology, Sao Paulo State University (UNESP)Abstract Background Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients’ behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP. Methods This study will be a two-group, single-blind, randomised controlled trial. One hundred and sixty adults with chronic, nonspecific LBP will be recruited. Participants allocated to both groups will receive a group exercise programme. In addition, the intervention group will receive health coaching sessions (i.e. assisting the participants to achieve their physical activity goals) and an activity monitor (i.e. Fitbit Flex). The participants allocated to the control group will receive sham health coaching (i.e. encouraged to talk about their LBP or other problems, but without any therapeutic advice from the physiotherapist) and a sham activity monitor. Outcome measures will be assessed at baseline and at 3, 6 and 12 months post randomisation. The primary outcomes will be physical activity, measured objectively with an accelerometer, as well as pain intensity and disability at 3 months post randomisation. Secondary outcomes will be physical activity, pain intensity and disability at 6 and 12 months post randomisation as well as other self-report measures of physical activity and sedentary behaviour, depression, quality of life, pain self-efficacy and weight-related outcomes at 3, 6, and 12 months post randomisation. Discussion This study is significant as it will be the first study to investigate whether a multimodal intervention designed to increase physical activity levels reduces pain and disability, and increases physical activity levels compared to a control intervention in patients with chronic LBP. Trial registration ClinicalTrials.gov, ID: NCT03200509 . Registered on 28 June 2017.http://link.springer.com/article/10.1186/s13063-017-2436-zLow back painPhysical activityExercise therapyHealth coachingActivity monitor
spellingShingle Crystian B. Oliveira
Márcia R. Franco
Chris G. Maher
Anne Tiedemann
Fernanda G. Silva
Tatiana M. Damato
Michael K. Nicholas
Diego G. D. Christofaro
Rafael Z. Pinto
The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
Trials
Low back pain
Physical activity
Exercise therapy
Health coaching
Activity monitor
title The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
title_full The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
title_fullStr The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
title_full_unstemmed The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
title_short The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
title_sort efficacy of a multimodal physical activity intervention with supervised exercises health coaching and an activity monitor on physical activity levels of patients with chronic nonspecific low back pain physical activity for back pain payback trial study protocol for a randomised controlled trial
topic Low back pain
Physical activity
Exercise therapy
Health coaching
Activity monitor
url http://link.springer.com/article/10.1186/s13063-017-2436-z
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