Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
研究概览
简要总结
The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.
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)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain for >6 months
- •>3 pain episodes per week
- •waist circumferences ≥102 cm for men
- •waist circumferences ≥ 88 cm for women
- •willing and able to participate in regular exercise for 14 weeks
- •using pain medications to control low back pain
- •free of abnormal cardiovascular responses during a screening graded maximal walk test
排除标准
- •unable to walk
- •participating in regular resistance exercise training (>3X week) in the past 6 months
- •pain symptoms are too severe and prevent strength testing or walking
- •acute back injury
- •spinal stenosis that precludes walking one block due to neurogenic claudication
- •back surgery within the past 2 years
- •current use of weight loss interventions (drugs; exercise interventions)
结局指标
主要结局
Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baseline, 1, 2, 3 and 4 Months
Fear avoidance beliefs will be measured using the 11 item TSK. Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baseline, 1, 2, 3 and 4 Months
The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable. Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baseline, 1, 2, 3 and 4 Months
The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures. Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baseline, 1, 2, 3, and 4 Months
The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures. Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baselinje, 1, 2, 3 and 4 Months
The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain. Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
时间窗: Baseline, 1, 2, 3 and 4 Months
The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness. Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.
次要结局
- Ultrasound Muscle Thickness; Change from Baseline at 4 Months(Baseline and 4 Months)
- 7-day Pedometer Test; Change from Baseline at 4 Months(7 day period at Baseline and 4 Months)
- Graded Treadmill Exercise Test; Change from Baseline at 4 Months(Baseline and 4 Months)
- Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months(Baseline, 1, 2, 3 and 4 Months)
- Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months(Baseline and 4 Months)