Impact of Physical Activity for Chronic Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Physical Activity for Chronic Pelvic Pain

Conditions
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Pelvic Pain

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Behavioral: Physical Activity<br>* 8 week exercise program specifically designed for patients with chronic pain at Transitions Training Studio, a rehab-focused, medically-based fitness center based at the University of Michigan. The program is designed to gradually increase intensity and duration. If causes pain exacerbation, patients will go back to earlier level of intensity. It favors short, frequent activity episodes as this is often better tolerated than longer, infrequent episodes. The program begins with 30 minutes sessions 3 times per week with goal of increasing duration over course of the program. The program incorporates elements of flexibility, strength and cardio. Program design includes common elements but allows for a personalized program based on a subject's baseline fitness, interest and tolerance to activity. The program design emphasizes activities that patients can incorporate into their daily routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Change in reported pain after physical activity intervention, measured using VAS and Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | Change in reported physical function, measured by the PROMIS Physical Function Scale | 8 weeks | 
| Fatigue | Change in reported fatigue, measured by the PROMIS Fatigue Scale | 8 weeks | 
| Sexual Function | Change in reported sexual function, measured by the Female Sexual Function Index | 8 weeks | 
| Sleep | Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale | 8 weeks | 
| Anxiety | Change in reported anxiety, measured by the PROMIS Anxiety Scale | 8 weeks | 
| Depression | Change in reported depression, measured by the PROMIS Depression Scale | 8 weeks | 
| Catastrophization | Change in reported catastrophization, measured by the Pain Catastrophization Scale | 8 weeks | 
| Overall symptom improvement | Change in overall symptoms, measured by the Patient Global Impression of Change Scale | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pelvic pain, central pain amplification, exercise, physical activity