The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Changes in pain severity
研究概览
简要总结
Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.
详细描述
Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.
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
Single
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-specific low back pain
- •Must be pain at least 3 months
排除标准
- •History of any lumbar spine surgery
- •Presence of neurological deficit
- •Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
- •The presence of persistent severe pain
- •Pain below the knee
- •Severe/progressive scoliosis
- •Spinal stenosis
- •Spondylolisthesis
- •Metabolic syndrome
- •Inflammatory, infectious or tumoral disease of the vertebra
结局指标
主要结局
Changes in pain severity
时间窗: change from baseline in pain severity at 8 weeks
Patients' average resting, activity and night pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.
Changes of functional status
时间窗: change from baseline in functional status at 8 weeks
Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound.
次要结局
- Changes in gait parameters(Change from baseline in gait parameters at 8 weeks)
- Changes in metabolic capacity(Change from baseline in metabolic capacity at 8 weeks)
- Changes in alexithymia(Change from baseline in alexithymia at 8 weeks)
- Changes in quality of life(Change from baseline in life quality levels at 8 weeks)
- Changes in kinesiophobia.(Change from baseline in kinesiophobia at 8 weeks)
- Changes in cognitive level(Change from baseline in cognitive level at 8 weeks)
- Changes in back awareness(Change from baseline in back awareness at 8 weeks)
研究者
Muzeyyen Oz
Research Assistant, Neck and Low Back Health Unit, Principal Investigator, MSc
Hacettepe University