Exercise Training in Postmenopausal Patients With Breast Cancer

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: physical activity; Behavioral: Counseling

• Registration Number: NCT01384838
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary

This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.

All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.

All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.

Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Signed informed consent
• Postmenopausal women with hormone receptor positive breast cancer (as defined by HR >= ++ and/or PR >= ++) who are treated with aromatase inhibitors
• ECOG performance status <= 2
• all age groups

Exclusion Criteria

• Pathologic ergometry
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension
• COPD > II
• Active opportunistic infection
• NYHA heart failure III or IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controlled physical activity	physical activity	All patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
Counseling	Counseling	Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.

Primary Outcome Measures

Name	Time	Method
Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.	after 6 months

Secondary Outcome Measures

Name	Time	Method
Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis	after 6 and 12 months
Evaluation of the influence of controlled/observed physical activity versus lifestyle counseling only on Fitness level, Quality of Life, rate of infections, weight, body mass index BMI, Body fat percentage	after 6 and 12 months

Trial Locations

Locations (1)

Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum; 🇦🇹 Salzburg, Austria