Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2016-08-31
2017-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Physical Activity
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.
Interventions
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Physical Activity
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Sara Till, MD, MPH
Minimally Invasive Gynecologic Surgery Fellow
Principal Investigators
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Sawsan As-Sanie, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Sara R Till, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 51. Chronic pelvic pain. Obstet Gynecol. 2004 Mar;103(3):589-605. No abstract available.
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Other Identifiers
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HUM00112656
Identifier Type: -
Identifier Source: org_study_id
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