Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Pain Intensity:
研究概览
简要总结
This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups:
Combined intervention group: Pilates plus resistance training
Single intervention group: Pilates alone
Control group: Advices only
All interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.
详细描述
This study will investigate the effects of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances in the Gaza Strip. The study will use a 3-arm randomized controlled trial design, with participants randomly assigned to one of three groups:
Combined Intervention Group: Pilates plus resistance training
Single Intervention Group: Pilates or resistance training alone
Control Group: Usual care
The intervention groups will participate in 2 supervised sessions per week for 8 weeks. The control group will continue their usual care without structured or supervisedexercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed with chronic low back pain (CLBP), defined as pain localized between the lower rib margin and gluteal folds, lasting ≥12 weeks.
- •Sleep Quality: Poor sleep quality, defined as PSQI global score >5.
排除标准
- •Specific LBP causes: Low back pain due to fractures, tumors, infections, inflammatory disorders, or systemic disease.
- •Recent spinal surgery: History of lumbar spine surgery within the past 12 months.
- •Severe comorbidities: Serious cardiovascular, respiratory, neurological, or musculoskeletal disorders that contraindicate exercise.
- •Pregnancy or planned pregnancy during the study period.
- •Current participation in structured exercise programs targeting the back (Pilates, resistance training, or core stabilization) within the last 3 months.
- •Use of sleep medications or interventions that cannot be maintained stable during the study period.
结局指标
主要结局
Pain Intensity:
时间窗: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Measured using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." It captures the patient's perceived pain severity.
Disability
时间窗: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Oswestry Disability Index (ODI) The Oswestry Disability Index (ODI) is a widely used, validated questionnaire that assesses functional disability in individuals with low back pain. It measures the impact of back pain on a person's ability to perform activities of daily living (ADL) and overall functional limitations. Structure: The ODI contains 10 sections, each focusing on a different aspect of daily function: Pain intensity Personal care (washing, dressing) Lifting Walking Sitting Standing Sleeping Social life Traveling Employment/homemaking Each section has 6 statements scored from 0 to 5, with higher scores indicating greater disability.
Sleep_ Pittsburgh Sleep Quality Index (PSQI)
时间窗: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported questionnaire used to assess sleep quality and disturbances over the past month. It is widely used in clinical and research settings, including studies on chronic pain and musculoskeletal disorders. Structure: The PSQI consists of 19 individual items combined into 7 components: Subjective sleep quality - the individual's perception of their sleep Sleep latency - time taken to fall asleep Sleep duration - total hours of sleep per night Habitual sleep efficiency - percentage of time in bed actually spent sleeping Sleep disturbances - factors causing sleep interruptions (e.g., waking up, pain, environmental disturbances) Use of sleep medication - frequency of taking sleep aids Daytime dysfunction - difficulty staying awake or maintaining function during the day Scoring: Each component is scored from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to generate a global PSQI score
次要结局
未报告次要终点
研究者
Mosab ALdabbas
ASSISTANT PROFESSOR AT AL AZHAR UNIVERSITY
Al-Azhar University