"Efficacy of the WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life in Sedentary Overweight and Obese Middle-Aged Women: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).
详细描述
Participants (aged 45-65, BMI ≥25 kg/m², chronic LBP ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). Both groups completed three 60-minute sessions/week for 8 weeks. Assessments occurred at baseline, post-intervention, and 3-month follow-up. Primary outcomes: VAS and ODI; secondary outcomes: SF-36 and satisfaction.
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-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 45-65, BMI ≥25 kg/m².
- •Sedentary (<150 min/week moderate activity).
- •Chronic LBP (≥3 months, VAS ≥4).
排除标准
- •Contraindications to exercise (e.g., severe cardiovascular disease).
- •Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).
结局指标
主要结局
Pain Intensity
时间窗: Baseline, 8 weeks (post-intervention), 3-month follow-up
Visual Analog Scale (VAS), Scale Range: 0 (no pain) to 10 (worst pain imaginable),
Functional Disability
时间窗: Baseline, 8 weeks (post-intervention), 3-month follow-up
Oswestry Disability Index (ODI), Scale Range: 0% (no disability) to 100% (severe disability)
次要结局
- Health-Related Quality of Life (HRQoL)(Baseline, 8 weeks (post-intervention), 3-month follow-up)
- Participant Satisfaction(8 weeks (post-intervention), 3-month follow-up)
研究者
Mohammadreza Rezaeipour
Assoc.Prof.Dr
University of Sistan and Baluchestan