NCT01102985

Women With Cancer: An Exercise Study to Promote Health

An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.

Detailed description

The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).

Conditions

• Bone Loss
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	aerobic resistance exercise	three times per week aerobic resistance exercise for 12 months
BEHAVIORAL	home based health promotion	education and support to adapt national guidelines for 30 minutes physical activity most days of the week

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-04-13
• Last updated: 2015-07-01

Locations

1 site across 1 country: United States