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Physical ActivityNCT01384838

Exercise Training in Postmenopausal Patients With Breast Cancer

A study testing Counseling and physical activity in people with Physical Activity, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Physical Activity
What is being tested?
Counseling and physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteAustria
Study dates
Jun 2011to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum

    Salzburg, 5020

Other trials in Austria

About this study

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

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.

Read more

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.

Being tested
Counseling, physical activity
Keywords
breast cancer, physical activity, sports, exercise
Medical subject headings
Motor Activity, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CounselingBehavioural

    Nutritional, lifestyle and sports counseling

  • physical activityBehavioural

    counseling and controlled physical activity

Study groups in NCT01384838
Study groupRoleWhat they receive
CounselingOtherPatients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
Receives: Behavioral: Counseling
Controlled physical activityExperimentalAll 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.
Receives: Behavioral: physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: after 6 months

Secondary outcomes (2)

  1. Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis

    Measured: after 6 and 12 months

  2. 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

    Measured: after 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01384838
Sponsor's protocol ID
AGMT_BC_Sports
Status last verified
Jun 2015
First submitted
28 Jun 2011
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Westphal T, Rinnerthaler G, Gampenrieder SP, Niebauer J, Thaler J, Pfob M, Fuchs D, Riedmann M, Mayr B, Reich B, Melchardt T, Mlineritsch B, Pleyer L, Greil R. Supervised versus autonomous exercise training in breast cancer patients: A multicenter randomized clinical trial. Cancer Med. 2018 Dec;7(12):5962-5972. doi: 10.1002/cam4.1851. Epub 2018 Nov 10.

    PubMed 30415507

Questions about this trial

What is this clinical trial studying?

A study testing Counseling and physical activity in people with Physical Activity, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity. (time frame: after 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01384838, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015; AzTrials last refreshed its copy on 26 Oct 2026.

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