NCT01684579

Exercising Our ABC's (African- American Breast Cancer Survivors)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent studies have shown that some behavioral factors such as physical activity and exercise may improve quality of life and outcome in patients with breast cancer as well as decrease body fat, increase lean mass and reduce cancer-promoting hormones. None of these studies have been performed in African-American women with breast cancer. The medical field needs to understand how exercise may benefit cancer patients, particularly African Americans, and how to optimize these benefits to improve the quality of life, prognosis and survival.

Detailed description

All exercise training will take place at the Gathering Place, Beachwood OH, in the new Wellness Center that is equipped with state-of-the-art aerobic and resistance training apparati. All exercise will be performed under the supervision of the Gathering Place trained and certified staff. The patient group will perform a 20 week aerobic and resistance exercise training program to evaluate (compared to baseline) changes: in body composition (fat, lean tissue and bone mass); cytokines including insulin, leptin, adiponectin, IL-6, and TNFα; oxidative stress including urine isoprostane; cardiorespiratory fitness (VO2max); upper and lower body strength (assessed using a dynamometer); sleep (assessed using the Pittsburgh Sleep Quality Index \[PSQI\]); fatigue and quality of life (Qol) (assessed using the SF-36, FACIT instruments). Patients will be evaluated before and after a 20 week intervention and a 10 week post-intervention period. Participants also will be evaluated for motivation barriers and compliance. These feasibility parameters will provide the basis and guidance for an NCI grant application to focus on mechanisms and extend our evaluation to larger cohorts of African-American patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Resistance Exercise	Resistance exercise will be performed 2 days per week for 18 weeks. The resistance training protocol will follow the Resistance Training Strategies for Individuals With Cancer (RTSFIC). The goals will be to keep intensity levels low at the outset (having lighter weights and more reps) and progress slowly and safely. Training prescriptions will be modified based on the training level of the patients and their progress.
BEHAVIORAL	Aerobic Exercise	A 20-week aerobic walking exercise program will be developed for each participant based on results of initial exercise testing and prescribed to be done 5 or more days per week designed to progress from moderate exercise intensity, (50-70% maximum heart rate), to vigorous exercise intensity (75-85% maximum heart rate). Maximum heart rate (HR max) will be determined as the peak heart rate achieved during initial cardiopulmonary exercise screening. Heart rate during exercise will be monitored by participants using wrist monitors, already available through TREC Program. Patient progress will also be evaluated using a six minute walk test (6MWT), which will be conducted at TGP at baseline, 6, 12 and 18 weeks and, after completion of the intervention.
BEHAVIORAL	Behavioral Group Counseling	The psychosocial component of the 20-week exercise program includes a 1 ½ hour support group offered prior to one of the weekly exercise classes.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2013-03-01
• First posted: 2012-09-13
• Last updated: 2013-03-20

Locations

2 sites across 1 country: United States