University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT02867774
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.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8 weeks
Change in reported pain after physical activity intervention, measured using VAS and Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
Time frame: 8 weeks
Change in reported physical function, measured by the PROMIS Physical Function Scale
Time frame: 8 weeks
Change in reported fatigue, measured by the PROMIS Fatigue Scale
Time frame: 8 weeks
Change in reported sexual function, measured by the Female Sexual Function Index
Time frame: 8 weeks
Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale
Time frame: 8 weeks
Change in reported anxiety, measured by the PROMIS Anxiety Scale
Time frame: 8 weeks
Change in reported depression, measured by the PROMIS Depression Scale
Time frame: 8 weeks
Change in reported catastrophization, measured by the Pain Catastrophization Scale
Time frame: 8 weeks
Change in overall symptoms, measured by the Patient Global Impression of Change Scale
University of Michigan
Other
Acronym: IPA-CPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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