Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Physical Activity for Chronic Pelvic Pain (IPA-CPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02867774
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Till, MD, MPH, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Behavioral: Physical Activity Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: 8 weeks ]
    Change in reported physical function, measured by the PROMIS Physical Function Scale

  2. Fatigue [ Time Frame: 8 weeks ]
    Change in reported fatigue, measured by the PROMIS Fatigue Scale

  3. Sexual Function [ Time Frame: 8 weeks ]
    Change in reported sexual function, measured by the Female Sexual Function Index

  4. Sleep [ Time Frame: 8 weeks ]
    Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale

  5. Anxiety [ Time Frame: 8 weeks ]
    Change in reported anxiety, measured by the PROMIS Anxiety Scale

  6. Depression [ Time Frame: 8 weeks ]
    Change in reported depression, measured by the PROMIS Depression Scale

  7. Catastrophization [ Time Frame: 8 weeks ]
    Change in reported catastrophization, measured by the Pain Catastrophization Scale

  8. Overall symptom improvement [ Time Frame: 8 weeks ]
    Change in overall symptoms, measured by the Patient Global Impression of Change Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Sawsan As-Sanie, MD, MPH University of Michigan
Principal Investigator: Sara R Till, MD, MPH University of Michigan

Publications of Results:

Layout table for additonal information
Responsible Party: Sara Till, MD, MPH, Minimally Invasive Gynecologic Surgery Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT02867774     History of Changes
Other Study ID Numbers: HUM00112656
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sara Till, MD, MPH, University of Michigan:
chronic pelvic pain
central pain amplification
exercise
physical activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms