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Completed

NCT Number: NCT02867774

Impact of Physical Activity for Chronic Pelvic Pain

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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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: IPA-CPP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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