Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The goal of this randomized clinical trial] is to study the effect of a combined aquatic and land-based exercise program compared to an aquatic program on pain, functional disability, and quality of life in adults with chronic low back pain. The main question it aims to answer is: "Does a combined aquatic and land-based exercise program improve functional disability and quality of life and reduce pain in adults with chronic low back pain?".
Participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group).
Researchers will compare groups to find any differences in pain, funcional disability and quality of life.
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
- Double (Care Provider, 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
- •Both gender;
- •Portuguese nationality;
- •Aged over 18 years;
- •Chronic Low Back Pain lasting three months or longer and with an intensity of 3 or higher on the Visual Analogue Scale at rest.
排除标准
- •Individuals who refuse to participate or do not provide informed consent;
- •Pain radiating to the lower limb;
- •Recent pregnancy or childbirth (less than 8 weeks ago);
- •Ongoing physical therapy treatments;
- •Severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention;
- •History of spinal surgery;
- •Inflammatory, infectious, or malignant spinal diseases;
- •Psychiatric disorders that may affect adherence and symptom assessment.
结局指标
主要结局
Pain
时间窗: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Functional Disability
时间窗: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with Oswestry Disability Index - version 2.0. (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Quality of life
时间窗: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with MOS Short Form Health Survey 36 Item v2. (Minimum: 0; Maximum 100). Higher values correspond to better outcome.
次要结局
- Lumbar spine range of motion(From enrollment to the end of treatment at 8 weeks)
- Fear of movement or (re)injury(From enrollment to the end of treatment at 8 weeks)
研究者
Joana Catarina Carvalho Borges
Principal Investigator
Instituto Politécnico de Leiria