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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
Sponsor:
Information provided by (Responsible Party):
Sara Till, MD, MPH, University of Michigan

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date March 1, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02867774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Physical Activity for Chronic Pelvic Pain
Official Title  ICMJE Impact of Physical Activity for Chronic Pelvic Pain
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Pain
Intervention  ICMJE 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.

Study Arms  ICMJE 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).
Intervention: Behavioral: Physical Activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
25
Actual Study Completion Date  ICMJE December 28, 2017
Actual Primary Completion Date December 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867774
Other Study ID Numbers  ICMJE HUM00112656
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sara Till, MD, MPH, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sawsan As-Sanie, MD, MPH University of Michigan
Principal Investigator: Sara R Till, MD, MPH University of Michigan
PRS Account University of Michigan
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP