NCT02560662

Brief Summary

The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable breast-cancer

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

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

September 23, 2015

Last Update Submit

January 25, 2024

Conditions

Breast Cancer

Keywords

Breast cancer, physical exercise, recovery

Outcome Measures

Primary Outcomes (2)

  • Change in self-reported physical and psychological recovery

    Measured using validated questions within a questionnaire

    Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively

  • Sick leave

    Data from the Swedish Social Insurance Agency (Försäkringskassan) on total number of days and the reasons (diagnosis) for any sick-leave episodes

    12 months postoperatively

Secondary Outcomes (5)

  • Length of hospital stay

    30 days postoperatively

  • Adverse events

    90 days postoperatively

  • Re-operations and re-admittances

    12 months postoperatively

  • Mortality

    3 and 5 years postoperatively

  • Health economy

    12 months postoperatively

Study Arms (2)

Physical activity

EXPERIMENTAL

Individual consultation with a physiotherapist in order to increase the participants existing level of physical activity by adding 30minutes of physical activity daily, preoperatively and 4 weeks postoperatively.

Behavioral: Physical activity

Control

NO INTERVENTION

Participants randomized to the control group will not be advised to change their current level of physical activity.

Interventions

Physical activityBEHAVIORAL

Preoperative intervention - takes place from randomization until surgery (4 weeks +/-2 w): • 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort. Postoperative intervention - takes place from discharge from the hospital until 4 weeks postoperatively: • 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort. Participants randomized to intervention will receive a visit to a physiotherapist for personally adjusted information regarding the intervention, later followed up with a telephone call.

Physical activity

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate.

You may not qualify if:

  • Inability to understand given information.
  • Withdrawal of informed consent.
  • Male sex.
  • Stage IV breast cancer at diagnosis.
  • Neoadjuvant breast cancer treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (2)

  • Heiman J, Onerup A, Bock D, Haglind E, Olofsson Bagge R. The effect of nonsupervised physical activity before and after breast cancer surgery on quality of life: Results from a randomized controlled trial (PhysSURG-B). Scand J Surg. 2022 Dec;111(4):75-82. doi: 10.1177/14574969221123389. Epub 2022 Sep 15.

    PMID: 36113110DERIVED

  • Heiman J, Onerup A, Wessman C, Haglind E, Olofsson Bagge R. Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial. Br J Surg. 2021 Jan 27;108(1):32-39. doi: 10.1093/bjs/znaa007.

    PMID: 33640941DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Roger Olofsson Bagge, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

January 27, 2016

Primary Completion

March 10, 2019

Study Completion

February 11, 2020

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)