Exercise Training in Postmenopausal Patients With Breast Cancer

Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384838

Enrollment

Registered

2011-06-29

Start date

2011-06-30

Completion date

2015-04-30

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

breast cancer, physical activity, sports, exercise

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.

Interventions

BEHAVIORALCounseling

Nutritional, lifestyle and sports counseling

BEHAVIORALphysical activity

counseling and controlled physical activity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026