NCT01515124

The Women In Steady Exercise Research (WISER) Survivor Trial

The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 80 Years
• Healthy volunteers: Accepted

Summary

WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.

Conditions

• Lymphedema

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.
BEHAVIORAL	Weight Loss Intervention	The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-01-23
• Last updated: 2022-10-10

Locations

1 site across 1 country: United States