Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Numeric Pain Rating Scale
研究概览
简要总结
This is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a recumbent cycling ergometer. This feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.
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
- Single (Outcomes Assessor)
盲法说明
The physician screening participants and the primary outcome assessor will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Confirmed chronic (>12 weeks) low back pain at screening assessment (based on patient history)
- •Ability to comply with the current Mount Sinai Health system COVID-19 requirements for research participants (e.g., vaccination, masks)
排除标准
- •Criteria will be evaluated during the clinical evaluation at the screening visit. All determinations will be the decision of the study physician:
- •Less than 2/10 low back pain on 0-10 numeric rating scale for average pain over past 7 days at baseline assessment
- •Any cardiovascular or musculoskeletal contraindication to exercise
- •Impaired balance contraindicating exercise
- •Known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments
- •Current pregnancy
- •Current medications or new medications commenced that may impact the ability for change to be detected in study
- •Any other contraindication in the opinion of the study physician
研究组 & 干预措施
Vertical climbing ergometer exercise
8 weeks of 3 times per week (24 sessions in total) of 30 minutes of vertical climbing ergometer exercise using the CLMBR. Intensity will be prescribed at a level of 12 to 14 on the Borg Rate of Perceived Exertion Scale.
干预措施: Vertical climbing ergometer exercise (Other)
Recumbent cycling
8 weeks of 3 times per week (24 sessions in total) of 30 minutes of recumbent cycle ergometer exercise. Intensity will be prescribed at a level of 12 to 14 on the Borg Rate of Perceived Exertion Scale.
干预措施: Recumbent cycling (Other)
结局指标
主要结局
Change in Numeric Pain Rating Scale
时间窗: Baseline and 8 Weeks
11-point numerical rating scale evaluating average pain intensity over the past 7 days. A clinically meaningful difference will be considered as 2 points. Change in Numeric Pain Rating scale at 8 weeks as compared to baseline. Full scale from 0-10, with higher score indicating more pain.
Incidence of adverse events
时间窗: 8 Weeks
Incidence of adverse events
Number of completed exercise sessions
时间窗: 8 Weeks
The number of completed exercise sessions. A completed session is defined as achieving a minimum of 15 minutes of active exercise during a commenced session.
次要结局
- Numeric Pain Rating Scale(8 weeks)
- Minutes of exercise completed(8 weeks)
- Change in The Oswestry Disability Index(Baseline and 8 weeks)
研究者
Jamie Mathew Wood
Program Manager
Icahn School of Medicine at Mount Sinai