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| Name | Class |
|---|---|
| University of Sydney | OTHER |
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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 programs for chronic LBP is that these programs are not designed to change patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Intervention | Experimental | The participants from both groups will receive a group exercise program, including a combination of general, stabilisation, strengthening and resistance exercises. In addition, the intervention group will receive health coaching sessions and an activity monitor. |
|
| Control group | Sham Comparator | The participants from both groups will receive a group exercise program, including a combination of general, stabilisation, strengthening and resistance exercises. The participants allocated to the control group will receive sham health coaching and a sham activity monitor, in addition to the exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Intervention | Other | Participants will receive a group exercise program, health coaching sessions and an activity monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity levels - Counts per minute | Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | Post-intervention (i.e. 3 months after randomisation) |
| Pain intensity | Numerical Rating Scale for Pain assessment (NRS) (0-10) | Post-intervention (i.e. 3 months after randomisation) |
| Disability | Roland Morris Disability Questionnaire (RMDQ) (0-24) | Post-intervention (i.e. 3 months after randomisation) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity levels - Counts per minute | Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | 6 and 12-month assessment after randomisation |
| Pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sao Paulo State University | Presidente Prudente | São Paulo | 19060900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29334992 | Background | Oliveira CB, Franco MR, Maher CG, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Christofaro DGD, Pinto RZ. 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. 2018 Jan 15;19(1):40. doi: 10.1186/s13063-017-2436-z. | |
| 35536245 |
| Label | URL |
|---|---|
| Physical Activity Interventions for Increasing Objectively Measured Physical Activity Levels in Patients With Chronic Musculoskeletal Pain: A Systematic Review | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor. |
|
Numerical Rating Scale for Pain assessment (NRS) (0-10)
| 6 and 12-month assessment after randomisation |
| Disability | Roland Morris Disability Questionnaire (RMDQ) (0-24) | 6 and 12-month assessment after randomisation |
| Physical activity levels - light physical activity | Time spent in light physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Physical activity levels - moderate-to-vigorous physical activity | Time spent in moderate-to-vigorous physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Physical activity levels - steps | Number of steps will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Sedentary behavior | Time spent in sedentary behavior will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Self-reported physical activity level | Baecke Habitual Physical Activity Questionnaire | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Self-reported sedentary behavior | Questions about the time spent in sedentary behavior | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Depression | The Center for Epidemiological Studies - Depression (CES-D) scale (0-60) | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| General quality of life | EuroQol visual analogue scale (EQ-VAS) (0-100) | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ) (0-60) | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Weight-related outcomes - Body mass index | Body mass index | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Weight-related outcomes - Waist-to-hip circumference | Waist-to-hip circumference | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up |
| Global Perceived Effect Scale (GPES) | Perception of recovery | Post-intervention (i.e. 3 months after randomisation) |
| Derived |
| Oliveira CB, Christofaro DGD, Maher CG, Franco MR, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Pinto RZ. Adding Physical Activity Coaching and an Activity Monitor Was No More Effective Than Adding an Attention Control Intervention to Group Exercise for Patients With Chronic Nonspecific Low Back Pain (PAyBACK Trial): A Randomized Trial. J Orthop Sports Phys Ther. 2022 May;52(5):287-299. doi: 10.2519/jospt.2022.10874. |
| Unlocking the potential of physical activity for back health | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |