Impact of Physical Activity for Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The purpose of this pilot study is to evaluate the impact of an intervention to increase physical activity on pain, function and quality of life in women with chronic pelvic pain.
详细描述
The primary aim of this pilot study is to evaluate the impact of moderate-intensity physical activity on pelvic pain in women with chronic pelvic pain. We will develop a moderate-intensity physical activity program for patients with chronic pelvic pain in conjunction with exercise physiologists and physical medicine and rehabilitation (PM&R) physicians. Based on prior research in fibromyalgia and other centralized pain disorders, we hypothesize that eight weeks of moderate-intensity physical activity will reduce pain intensity and pain interference in women with chronic pelvic pain. We will also evaluate the impact of moderate-intensity physical activity on physical function, fatigue, sexual function, sleep, anxiety, depression, catastrophization and patient global impression of change in women with chronic pelvic pain. We hypothesize that eight weeks of moderate-intensity physical activity will result in improvements in these measures of function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-65 years old
- •≥ 6 months of noncyclic pelvic pain
- •Pain that is severe enough to cause functional limitations, defined here as an average self-reported daily pain score of 4 on a 10 point scale
- •Willing to attend activity session in Ann Arbor, MI at least 3 times per week
- •English speaking
排除标准
- •Pelvic surgery within the previous 3 months or plan for pelvic surgery within the following 3 months
- •Participation in pelvic floor physical therapy during the 12 week study period
- •Medical co-morbidities that prohibit participation in an exercise program, such as significant cardiovascular, pulmonary or orthopedic disease
- •Pregnancy
- •Documented history of significant dementia
研究组 & 干预措施
Intervention
This pilot study will enroll 25 women age 18-65 with greater than six months of noncyclic pelvic pain. Subjects will participate in an 8-week physical activity program specifically designed for patients with chronic pain and supervised by personal trainers and exercise physiologists in a rehab-focused, medically-based fitness center. Subjects will complete web-based assessment tools at the start of the program, immediately after completion of the 8-week program and four weeks after the conclusion of the program (at the 12-week time point).
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
Pain
时间窗: 8 weeks
Change in reported pain after physical activity intervention, measured using VAS and Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
次要结局
- Physical Function(8 weeks)
- Fatigue(8 weeks)
- Sexual Function(8 weeks)
- Sleep(8 weeks)
- Anxiety(8 weeks)
- Depression(8 weeks)
- Catastrophization(8 weeks)
- Overall symptom improvement(8 weeks)
研究者
Sara Till, MD, MPH
Minimally Invasive Gynecologic Surgery Fellow
University of Michigan