NCT02867774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

August 12, 2016

Last Update Submit

February 27, 2018

Conditions

Pelvic Pain

Keywords

chronic pelvic paincentral pain amplificationexercisephysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Physical Function

    8 weeks

  • Fatigue

    8 weeks

  • Sexual Function

    8 weeks

  • Sleep

    8 weeks

  • Anxiety

    8 weeks

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Physical ActivityBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (31)

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    PMID: 26084281RESULT

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    PMID: 24362925RESULT

  • Kayo AH, Peccin MS, Sanches CM, Trevisani VF. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial. Rheumatol Int. 2012 Aug;32(8):2285-92. doi: 10.1007/s00296-011-1958-z. Epub 2011 May 19.

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    PMID: 25939406RESULT

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MeSH Terms

Conditions

Pelvic PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sawsan As-Sanie, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Sara R Till, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Minimally Invasive Gynecologic Surgery Fellow

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 16, 2016

Study Start

August 1, 2016

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)