Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Change in back-specific activity limitations
研究概览
简要总结
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.
详细描述
Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly impairs functioning and health-related quality of life of elders, and has an important healthcare cost.
The 2 main treatment options for lumbar spinal stenosis are conservative or surgical treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.
The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.
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
- None
盲法说明
single-blind
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 50 year-old
- •radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
- •MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology
排除标准
- •inability to speak and/or read French language
- •inability or refusal to perform ergometric bicycle at home
- •patients already having an ergometric bicycle at home
- •history of lumbar spine surgery in the previous 12 months
- •cognitive disorders
- •severe neurologic or vascular disorders involving the lower limbs
- •contraindication to a rehabilitation program assessed by medical examination
- •people under tutorship or curatorship
- •protected adults
结局指标
主要结局
Change in back-specific activity limitations
时间窗: 4 months after-randomization
Mean change from baseline in mean back-specific activity limitations in the previous month using the self-administered Oswestry Disability Index (ODI) total score (0 no limitations and 100 maximal limitations).
次要结局
- Change in maximal walking distance(4 months post-randomization)
- Change in lumbar pain(4, 6 and 12 months post-randomization)
- Change in back-specific activity limitations(6 and 12 months post-randomization)
- Change in radicular pain(4, 6 and 12 months post-randomization)
- Change in the physical component of health-related quality of life(4, 6 and 12 months post-randomization)
- Change in lumbar spinal stenosis-specific activity limitations(4, 6 and 12 months post-randomization)
- Percentage of patients who undergo spinal surgery(From baseline to 12 months post-randomization)