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Exercise and Radiotherapy, a Good Combination?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01908023
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : April 28, 2017
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer
Actual Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: exercise Behavioral: exercise
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

Primary Outcome Measures :
  1. changes in physical performance [ Time Frame: from baseline to 6 weeks ]
    aerobic capacity (VO2peak)

Secondary Outcome Measures :
  1. perceived coping [ Time Frame: from baseline to 6 weeks ]
    Patient Activation Measure (PAM)

  2. Range of motion [ Time Frame: from baseline to 6 weeks ]
  3. quality of life [ Time Frame: from baseline to 6 weeks ]
    questionnaire SF-36

  4. activity level [ Time Frame: from baseline to 6 weeks ]
    International physical activity questionnaire

  5. balance [ Time Frame: from baseline to 6 weeks ]
    Functional Reach

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Surgery for breast cancer.
  • Completed chemotherapy treatment.
  • Radiotherapy is scheduled.

Exclusion Criteria:

  • metastatic disease
  • pregnancy
  • drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01908023

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St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
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Principal Investigator: Inger L Aamot, phd Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology Identifier: NCT01908023     History of Changes
Other Study ID Numbers: 2013/271
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
exercise therapy
oxygen consumption
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases