Impact of Physical Activity for Chronic Pelvic Pain

Pelvic Pain Clinical Trial

— IPA-CPP  

Official title:

Impact of Physical Activity for Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867774
• Other study ID #: HUM00112656
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: February 27, 2018
• Start date: August 2016
• Est. completion date: December 28, 2017

Study information

• Verified date: February 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Change in reported pain after physical activity intervention, measured using VAS and Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale	8 weeks
Secondary	Physical Function	Change in reported physical function, measured by the PROMIS Physical Function Scale	8 weeks
Secondary	Fatigue	Change in reported fatigue, measured by the PROMIS Fatigue Scale	8 weeks
Secondary	Sexual Function	Change in reported sexual function, measured by the Female Sexual Function Index	8 weeks
Secondary	Sleep	Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale	8 weeks
Secondary	Anxiety	Change in reported anxiety, measured by the PROMIS Anxiety Scale	8 weeks
Secondary	Depression	Change in reported depression, measured by the PROMIS Depression Scale	8 weeks
Secondary	Catastrophization	Change in reported catastrophization, measured by the Pain Catastrophization Scale	8 weeks
Secondary	Overall symptom improvement	Change in overall symptoms, measured by the Patient Global Impression of Change Scale	8 weeks