Breast NeoplasmsNCT01908023
Exercise and Radiotherapy, a Good Combination?
A study testing exercise in people with Breast Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Jan 2014
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for breast cancer.
- Completed chemotherapy treatment.
- Radiotherapy is scheduled.
Who cannot join
- metastatic disease
- pregnancy
- drug abuse
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner
Trondheim
About this study
Official title: Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer
Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.
- Conditions
- Breast Neoplasms
- Being tested
- exercise
- Keywords
- exercise therapy, oxygen consumption
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
One hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Not described Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in physical performance
aerobic capacity (VO2peak)
Measured: from baseline to 6 weeks
Secondary outcomes (5)
perceived coping
Patient Activation Measure (PAM)
Measured: from baseline to 6 weeks
Range of motion
Measured: from baseline to 6 weeks
quality of life
questionnaire SF-36
Measured: from baseline to 6 weeks
activity level
International physical activity questionnaire
Measured: from baseline to 6 weeks
balance
Functional Reach
Measured: from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Inger L Aamot, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908023
- Sponsor's protocol ID
- 2013/271
- Status last verified
- Apr 2017
- First submitted
- 23 Jul 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01908023
- Acronym / sponsor ID
- 2013/271
- Conditions
- Breast Neoplasms
- Keywords
- exercise therapy, oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2013 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery for breast cancer.
- Completed chemotherapy treatment.
- Radiotherapy is scheduled.
Key exclusion criteria (3 listed)
- metastatic disease
- pregnancy
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseOne hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation | Behavioural | exercise |
Primary outcome
changes in physical performance
Time frame: from baseline to 6 weeks
aerobic capacity (VO2peak)
5 secondary outcomes
perceived coping
Time frame: from baseline to 6 weeks
Range of motion
Time frame: from baseline to 6 weeks
quality of life
Time frame: from baseline to 6 weeks
activity level
Time frame: from baseline to 6 weeks
balance
Time frame: from baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inger L Aamot, phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Breast Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 3 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 28 Apr 2017. 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 Norway. 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?
changes in physical performance (time frame: from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2017; AzTrials last refreshed its copy on 2 Nov 2026.