Project Description Purpose of the research. The primary purpose of the research is to better understand back pain, back function and quality of life during pregnancy. Benefits of participating. I may receive benefits from participating in the research study. The benefits that I may expect to receive include increased feelings of energy and well being, increased muscle strength, increased flexibility, and an improved ability to perform physical tasks. Also, I will receive monetary compensation of up to $210 ($20 associated with each of the three testing sessions and $150 pro-rated over 16 weeks of the study during my pregnancy). I can withdraw from the study for medical reasons without a loss of benefits. Description of procedures. If I volunteer, my participation will involve the following: 1. I will obtain clearance to participate from my personal OB-GYN physician or pregnancy health care provider (i.e., midwife). 2. I will agree to be assigned at random to only one of three study “conditions”: Exercise During Pregnancy, Exercise After Pregnancy, or Health Education During Pregnancy followed by Exercise After Pregnancy 3. Regardless of what condition I am assigned to, on three separate occasions across 16 weeks during my second and third trimester (weeks 21, 33 and 37) I will visit the Exercise Psychology Laboratory and take 10 tests that require a total of about 45 minutes. Seven of the tests are questionnaires about my general health, mood, work attendance, physical activity, and sleep. One test involves me rating the location and intensity of any pain I have when gentle pressure is applied to my upper leg while I am lying on a table on my back with my knee bent and my foot on the table. The final test examines how well my back is functioning and involves low intensity physical tasks common during daily living such as picking up scarves off the floor, sweeping the floor, transferring laundry from a washer to a dryer, sitting on the floor and returning to a standing position in one continuous movement, and walking, including up and down stairs, with groceries. To see some of these tests click HERE . 4.If I am assigned to the “Health Education During Pregnancy followed by Exercise After Pregnancy” condition, then I will attend up to 7 pregnancy-related, evening education classes (~90 minutes long) or one Saturday class (8-hr) during a 16 week period beginning the first month of my second trimester. After my pregnancy is over, I will have the option of participating in a free supervised 16 week exercise program (described below). If I am assigned to this condition I will get the benefit of attending health education classes for free. 5. If I am assigned to the “Exercise After Pregnancy” then I will have the option of participating in a free supervised 16 week exercise program after my pregnancy is over (described below). 6. If I am assigned to the “Exercise During Pregnancy” condition, or if I am in the other conditions and elect to participate in the exercise program offered after my pregnancy, then I will participate in a twice per week, ~60 minutes per session, 16-week exercise class supervised by trained exercise specialists. The exercises will be performed at a moderate intensity (after a low intensity warm up) and focus on strengthening the muscles of the legs, back and trunk. Before each exercise session, I will complete a questionnaire inquiring about any recent pregnancy-related symptoms or changes in my health or medication usage. Also, my body weight, heart rate and blood pressure will be measured. This information will be used to help ensure that I can perform the exercises safely. During and after each exercise session my heart rate, how hard I feel I am exercising, and any symptoms of discomfort will be measured in order to monitor my safety. Discomforts I may experience . It is likely that I will experience temporary, minor muscle discomfort during the exercise program, especially at the beginning of the exercise program. Confidentiality. Any information the researcher obtains about me as a participant in this study, including my identity, will be held confidential. My identity will be coded, and all original data will be kept in a secured, limited access location. My identity will not be revealed in any publication of the results of this research. The only people who will know that I am a research participant will be the members of the research team or my OB-GYN physician or pregnancy health care provider . The results of this participation will be confidential. A copy of my test results and the study results will be made available to me. Reason for Removal from the Study. I will be required to stop participation in the study before it ends if: 1) there is a significant change in my medical condition, 2) the researchers discover that I have a medical condition that would make it unsafe for me to continue, 3) my doctor indicates that I need to withdraw, or 4) the researchers decide to stop the study. Eligibility – to learn whether you are eligible click HERE. |