NCT01908023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

July 23, 2013

Last Update Submit

April 26, 2017

Conditions

Breast Neoplasms

Keywords

exercise therapyoxygen consumption

Outcome Measures

Primary Outcomes (1)

  • changes in physical performance

    aerobic capacity (VO2peak)

    from baseline to 6 weeks

Secondary Outcomes (5)

  • perceived coping

    from baseline to 6 weeks

  • Range of motion

    from baseline to 6 weeks

  • quality of life

    from baseline to 6 weeks

  • activity level

    from baseline to 6 weeks

  • balance

    from baseline to 6 weeks

Study Arms (1)

exercise

EXPERIMENTAL
Behavioral: exercise

Interventions

exerciseBEHAVIORAL

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

exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • metastatic disease
  • pregnancy
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner

Trondheim, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Inger L Aamot, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

NO(1)