Chronic Non-Specific Low Back Pain: Investigating the Effectiveness of a Dual-Task Program as an Attention Distraction Strategy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence to exercise
研究概览
简要总结
This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.
详细描述
Participants will be stratified based on their level of physical activity according to the International Physical Activity Questionnaire (IPAQ) into:
- Low physical activity
- Moderate physical activity
- High physical activity
They will then be randomly assigned to one of two groups: (1) an experimental group using the attention distraction application during the standard exercise program and (2) a control group following the same standard exercise program without distraction. The intervention will last for 8 weeks, with participants attending three non-supervised sessions per week (total: 24 training sessions). Each session will last approximately 25-30 minutes. Adherence to the exercise program will be monitored through the EARS questionnaire and the distraction application (The total score ranges from 0 to 24, where a higher score reflects better adherence).
The intervention group sessions consist of 5 minute submaximal warm-up followed by 25 minutes of stabilisation and resistance training with exercises focused on strength and stabilisation while using the distraction application. The training will consist of two parts: warming-up and the resistance and stabilisation program. The resistance program will consist of 4 exercises: knee flexion, abdominal crunches, prone superman and leg extension. Each exercise will be performed for 3 sets of 10 repetitions with a rest of 30 sec corresponding to every set , and 1 minute between each exercise. The stabilisation program will consist of 3 exercises: bridge, plank and side plank. Each exercise will be performed for 3 sets of 1 repetition (maximum time) with a rest of 30 sec corresponding to every set and 1 minute between each exercise. Four levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by increasing the resistance band tension, by changing the base of support or my modifying the length of resistance level arm.
In the control group they will perform the same exercises without the distraction-based application.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Chronic non-specific low back pain (≥3 months)
- •No physical therapy or structured exercise program in the last 3 months
- •Willingness to use the attention distraction application (for the AD-APP group)
- •Completion of the International Physical Activity Questionnaire (IPAQ)
排除标准
- •History of spinal surgery
- •Neurological conditions affecting movement
- •Regular use of pain relief medication within the past two weeks
- •Pregnancy
- •Severe psychological disorders that may affect compliance
研究组 & 干预措施
Distraction Group
Experimental Group: Standard exercise program with Attention Distraction Application (AD-APP)
Participants in this group will:
- will be familiarized with the exercises on a separete day prior to testing.
- Perform exercises while using an application designed to distract attention in order to achieve a cognitive-motor dual task (exercise task and cognitive task).
- Follow the program for 8 weeks, attending non-supervised sessions per week. Every two weeks , there will be a progression that will be achieved by increasing the level of difficulty of each exercise.
- Adherence to the exercise program will be tracked through digital monitoring within the application.
- Stratified into IPAQ categories (low, moderate, high physical activity).
Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).
干预措施: Stabilisation exercise, resistance exercise and distraction task (Other)
Control Group
Control Group: Standard exercise program without Attention Distraction Application (AD-APP)
Participants in this group will:
- will be familiarized with the exercises on a separete day prior to testing.
- Perform the same exercises without attention distraction in order to achieve a single task (exercise task).
- Follow the program for 8 weeks, attending non-supervised sessions per week.
- Adherence to the exercise program will be tracked through EARS-GR.
- Stratified into IPAQ categories (low, moderate, high physical activity).
Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).
干预措施: stabilisation exercise and resistance exercises (Other)
结局指标
主要结局
Adherence to exercise
时间窗: During the 6 month intervention period
Measured through app recorded metrics including frequency of use per week (minutes)
Adherence to exercise
时间窗: During the 6 month intervention period.
Measured through app recorded metrics, including number of sessions (number)
Adherence to exercise
时间窗: Baseline, Week 8, and follow-up (6 months).
Exercise Adherence Rating Scale in Greek (EARS-GR). The Exercise Adherence Rating Scale (EARS) is a questionnaire used to assess how well individuals adhere to prescribed exercise programs. It utilizes a 5-point Likert scale for each item, with higher scores indicating better adherence. The total score ranges from 0 to 24, with higher scores representing greater adherence.
次要结局
- Pain Intensity(Baseline, Week 8, and follow-up (6 months).)
- Anxiety, Stress, and Depression(Baseline, Week 8, and follow-up (6 months).)
- Functionality(Baseline, Week 8, and follow-up (6 months).)
- Pain Catastrophizing(Baseline, Week 8, and follow-up (6 months).)
- Central Sensitization(Baseline, Week 8, and follow-up (6 months).)
- Kinesiophobia(Baseline, Week 8, and follow-up (6 months))
- Individual's health-related quality of life(Baseline, Week 8, and follow-up (6 months))
- Effect of Physical Activity Level(Analyzed post-intervention based on IPAQ stratification)
- Work Productivity(Baseline, Week 8, and follow-up (6 months))
- Lumbar Mobility(Baseline, Week 8, and follow-up (6 months).)
- Muscle Endurance(Baseline, Week 8, and follow-up (6 months).)
- Gait Analysis(Baseline, Week 8 and follow-up (6 months).)
- Gait analysis(Baseline, Week 8 and follow-up (6 months))
- Gait Analysis(Baseline, Week 8, and follow-up (6 months).)
- Gait Analysis(Baseline, week 8 and follow - up (6 months))
- Gait analysis(Baseline, week 8 and follow-up (6 months))
- Gait analysis(Baseline, Week 8 and follow- up (6 months))
研究者
Savvas Spanos
Supervising Professor Dr Savvas Spanos
University of Thessaly