|Grant Number:||5R01CA122658-05 Interpret this number|
|Primary Investigator:||Knobf, M. Tish|
|Project Title:||An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors|
DESCRIPTION (provided by applicant): The purpose of the proposed exercise intervention trial is to improve physiologic health outcomes in peri- menopausal and early postmenopausal female cancer survivors. This randomized controlled trial (RCT) will be the first to evaluate an endurance-resistance exercise intervention that targets disturbances in normal physiology related to cancer treatment and menopause. Specifically, the intervention is designed to preserve bone mass and body composition, to improve metabolic risk profile and to improve functional status. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma (N=150) who have completed definitive treatment (<3 years) and are within 5 years of menopause (induced or natural) will be recruited to participate in a 12 month RCT of an endurance-resistance exercise intervention versus a health promotion control group. The specific aims of the study are to: 1) evaluate the effect of the intervention on bone mass and body composition, 2) examine the effect of intervention on metabolic risk factors (lipids, fasting glucose, insulin resistance, Hemoglobin A1-C (Hb A-1C) and blood pressure) and 3) examine the effects of an exercise intervention on functional status. The experimental intervention is a 12 month endurance-resistance intervention, designed with ground and joint reaction forces to provide an increased osteogenic stimulus, delivered 3 times/week at a community fitness center with on-site study interventionists, supplemented by recommendations for 30 minutes of physical activity on > 2 other days. The health promotion control group will receive written recommendations for physical activity > 5 days per week. Both groups will receive dietary guidelines for cancer survivors and calcium and vitamin D supplementation. Data will be collected at baseline, 6 and 12 months. An exercise stress test, dual energy x-ray absorptiometry and serum biomarkers for bone re-modeling will provide the objective measures for the bone, body composition and functional ability and serum glucose, insulin resistance, Hemoglobin A-1C and lipids will describe the metabolic risk profile. The findings of this study will have significant implications for risk reduction in female cancer survivors.