The AWESOME Study (Active Women Exercising: Sensor Outcome Model Evaluation)

Overview

Status: Recruiting
Keywords: Pelvic Floor Disorder , Pelvic Floor
IRB Number: 00044693
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

During two standardized physical activity sessions, use intra-abdominal pressure data (such as mean peak pressure and total area under the pressure curve) generated by the wireless remote abdominal pressure system to

  1. describe intra-abdominal pressures during a wide variety of activities
  2. determine the reproducibility of intra-abdominal pressures during individual activity segments measured during the two sessions
  3. categorize data generated in Aim 2a to revise the current Strenuous Activity Index (initially developed by the investigators based on urodynamics laboratory measurements) to create a valid instrument that reflects distinct magnitudes of intra-abdominal pressure in women during leisure, household and occupational activities.

We also plan to better understand how intra-abdominal pressure data relate to other common measures of physical activity intensity.  Therefore, we also plan to describe the heart rate and perceived exertion responses to a wide variety of activities concomitantly with abdominal pressure measurement.

PEP Substudy Objectives:

PEP Aim 1:  to describe intraabdominal pressures (IAP) experienced by women during their daily lives, including recreation and simulated household and childcare lifting and carrying activities. 

PEP Aim 2:  to determine whether IAP is associated with walking speed, after adjusting for body mass index.

PEP Aim 3: to compare IAP during common lifting and carrying activities in which the same weight is held in different ways (consistent with how people lift and carry objects).

Home Activity Substudy objective:

To measure intra-abdominal pressure during daily activity over a 4-day period. This substudy is a pilot study to evaluate feasibility, comfort, and ease of use of the transducer and base station, as well as the quality of data collection. We will recruit up to 20 women in this sub-study (and therefore will increase the overall enrollment into AWESOME from 140 to 160).  After evaluating the results, we will determine whether or not to enlarge this study to one powered to understand differences in IAP between women performing different types of household or occupational work.  At that point, we will submit an IRB modification with details of a full study, including an analytic plan.  

Pilates Sub-Study

The goal of this research is to track intra-abdominal pressures (IAP) using a wireless remote abdominal pressure sensor that fits in the vagina of women performing various activities of daily living.We have previously tracked IAP in 60 women undergoing 41 activities such as running, stepping, lifting and jumping.During those trials a wireless intra-abdominal pressure sensor was monitored using a remote base station linked to a laptop computer.The data recorded by the base station was read and stored on the laptop for analysis. Since the conclusion of the previous study, development work progressed on the development of a remote base station.This remote base station performs all the tasks as the previous base station except that it stores pressure data in an on-board memory card. The PEP substudy (already approved) utilizes this newly formed base station to complete extended activity tasks outside a controlled laboratory environment.

The ‘Pilates Sub-Study’ will monitor intra-abdominal pressure of 20 women (age 18 to 60) undergoing Pilates exercises in a class format not exceeding 5 participants at a time. The woman will insert the sensor into the vagina.  A portable base station will be clipped to their pants to allow for free movement and wireless reliability. The participants will be guided through a 30 minute Pilates mat routine designed to incorporate smooth transition of the participants between poses and to closely simulate a typical Pilates mat class.  After the exercise routine has been concluded the same participants will then be lead through 30 minutes Pilates reformer routine.  We would like to video record the participants undergoing the procedure in order to better match intra-abdominal pressure data with movement.  We will collect no PHI other than the person’s name on the consent document.

 

Principal Investigator: Ingrid Nygaard
Department: Urogynecology
Co Investigator: Janet Shaw

Contact Information

Name:Amy Orr
Phone: 801-213-2774
Email: amy.orr@hsc.utah.edu

Inclusion Criteria

-Participants for the standardized activity session will be women at low risk for cardiovascular disease according to the Guidelines of the American College of Sports Medicine; this includes restricting age to 18 to 54 years and to those that answer “no” to all questions on the Physical Activity Readiness Questionnaire (PAR-Q, See Protocol Summary Appendix 1).
 
-Body mass index for inclusion will be >19 to <30 kg/m2.
 
-Women must not be menstruating at the time of the activity session.
 
-Participants must be able to do a strenuous and variable one-hour activity session on two separate occasions.

Substudy:  Participants who have enrolled in the AWESOME study and indicated on their consent document that they would like to be contacted for future research. 

PEP Substudy:  Participants enrolled for the PEP Substudy will need to meet the same inclusion/exclusion criteria as for the main AWESOME study. 

Home Activity Substudy: Participants enrolled for the Home Activity Substudy will need to meet the same inclusion/exclusion criteria as for the main AWESOME study with the exception that, since they are not doing prescribed physical activity, they do not need to meet the American College of Sports Medicine low-risk criteria, do not need to fall into a certain BMI category, and they do not need to be able to do a strenuous 1-hour activity session. Similar to AWESOME, they must be 18 years or older. Exclusions: experienced bulging beyond vagina, history of pelvic surgery other than hysterectomy, currently using vaginal contraceptive or pessary, experienced unusual vaginal bleeding or discharge, been pregnant or given birth in last 6 months, currently a prisoner.

Pilates Sub-Study:  Women enrolled for the Pilates sub-study will be age 18 to 60 and will be regular participants in Pilates mat or reformer sessions at least one time a week for the past 6 months. 

 

Exclusion Criteria

Women with a history of musculoskeletal injury in the last 3 months or who report a sensation of vaginal bulge will be excluded.