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: PAyBACK Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Physical activity levels - Counts per minute
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic nonspecific LBP, defined as pain and discomfort localised below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration
排除标准
- •Serious spine pathology (e.g. tumors, fractures, and inflammatory diseases)
- •Nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve)
- •Spinal surgery
- •Pregnancy
- •Illiteracy
- •Insufficient understanding of the Portuguese language
- •Cardiorespiratory Diseases fibromyalgia or any other musculoskeletal condition that may affect activity and movement will be excluded
研究组 & 干预措施
Physical Activity Intervention
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.
干预措施: Physical Activity Intervention (Other)
Control group
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.
干预措施: Control group (Other)
结局指标
主要结局
Physical activity levels - Counts per minute
时间窗: Post-intervention (i.e. 3 months after randomisation)
Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Pain intensity
时间窗: Post-intervention (i.e. 3 months after randomisation)
Numerical Rating Scale for Pain assessment (NRS) (0-10)
Disability
时间窗: Post-intervention (i.e. 3 months after randomisation)
Roland Morris Disability Questionnaire (RMDQ) (0-24)
次要结局
- Physical activity levels - Counts per minute(6 and 12-month assessment after randomisation)
- Disability(6 and 12-month assessment after randomisation)
- Physical activity levels - moderate-to-vigorous physical activity(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Sedentary behavior(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Pain intensity(6 and 12-month assessment after randomisation)
- Pain self-efficacy(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Weight-related outcomes - Body mass index(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Physical activity levels - light physical activity(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Self-reported physical activity level(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Depression(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Global Perceived Effect Scale (GPES)(Post-intervention (i.e. 3 months after randomisation))
- Physical activity levels - steps(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Self-reported sedentary behavior(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- General quality of life(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
- Weight-related outcomes - Waist-to-hip circumference(Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up)
研究者
Crystian Bitencourt Soares de Oliveira
PhD student
Universidade Estadual Paulista Júlio de Mesquita Filho