Impact of Physical Activity for Chronic Pelvic Pain (IPA-CPP)
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|ClinicalTrials.gov Identifier: NCT02867774|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Pain||Behavioral: Physical Activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Physical Activity for Chronic Pelvic Pain|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||December 28, 2017|
|Actual Study Completion Date :||December 28, 2017|
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
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.
- Pain [ 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
- Physical Function [ Time Frame: 8 weeks ]Change in reported physical function, measured by the PROMIS Physical Function Scale
- Fatigue [ Time Frame: 8 weeks ]Change in reported fatigue, measured by the PROMIS Fatigue Scale
- Sexual Function [ Time Frame: 8 weeks ]Change in reported sexual function, measured by the Female Sexual Function Index
- Sleep [ Time Frame: 8 weeks ]Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale
- Anxiety [ Time Frame: 8 weeks ]Change in reported anxiety, measured by the PROMIS Anxiety Scale
- Depression [ Time Frame: 8 weeks ]Change in reported depression, measured by the PROMIS Depression Scale
- Catastrophization [ Time Frame: 8 weeks ]Change in reported catastrophization, measured by the Pain Catastrophization Scale
- Overall symptom improvement [ Time Frame: 8 weeks ]Change in overall symptoms, measured by the Patient Global Impression of Change Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867774
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Sawsan As-Sanie, MD, MPH||University of Michigan|
|Principal Investigator:||Sara R Till, MD, MPH||University of Michigan|