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

Primary Purpose

Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring chronic pelvic pain, central pain amplification, exercise, physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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).

Outcomes

Primary Outcome Measures

Pain
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

Physical Function
Change in reported physical function, measured by the PROMIS Physical Function Scale
Fatigue
Change in reported fatigue, measured by the PROMIS Fatigue Scale
Sexual Function
Change in reported sexual function, measured by the Female Sexual Function Index
Sleep
Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale
Anxiety
Change in reported anxiety, measured by the PROMIS Anxiety Scale
Depression
Change in reported depression, measured by the PROMIS Depression Scale
Catastrophization
Change in reported catastrophization, measured by the Pain Catastrophization Scale
Overall symptom improvement
Change in overall symptoms, measured by the Patient Global Impression of Change Scale

Full Information

First Posted
August 12, 2016
Last Updated
February 27, 2018
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02867774
Brief Title
Impact of Physical Activity for Chronic Pelvic Pain
Acronym
IPA-CPP
Official Title
Impact of Physical Activity for Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
chronic pelvic pain, central pain amplification, exercise, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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 Measure Information:
Title
Pain
Description
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
Secondary Outcome Measure Information:
Title
Physical Function
Description
Change in reported physical function, measured by the PROMIS Physical Function Scale
Time Frame
8 weeks
Title
Fatigue
Description
Change in reported fatigue, measured by the PROMIS Fatigue Scale
Time Frame
8 weeks
Title
Sexual Function
Description
Change in reported sexual function, measured by the Female Sexual Function Index
Time Frame
8 weeks
Title
Sleep
Description
Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale
Time Frame
8 weeks
Title
Anxiety
Description
Change in reported anxiety, measured by the PROMIS Anxiety Scale
Time Frame
8 weeks
Title
Depression
Description
Change in reported depression, measured by the PROMIS Depression Scale
Time Frame
8 weeks
Title
Catastrophization
Description
Change in reported catastrophization, measured by the Pain Catastrophization Scale
Time Frame
8 weeks
Title
Overall symptom improvement
Description
Change in overall symptoms, measured by the Patient Global Impression of Change Scale
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sawsan As-Sanie, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara R Till, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Impact of Physical Activity for Chronic Pelvic Pain

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