NCT03635723

Brief Summary

This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 23, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

7.4 years

First QC Date

August 15, 2018

Last Update Submit

April 9, 2024

Conditions

Breast CancerMobility Limitation

Keywords

TechnologyRehabilitationWearablesBreast surgeryPhysical activityEnhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

  • Arm movements

    Arm movements as measured by wearable sensor

    Post-operative for 2-4 weeks

Study Arms (1)

Surgical

Having undergone a procedure in hospital

Device: Activity monitor

Interventions

Activity monitorDEVICE

Technology allowing measurement of physical activity

Surgical

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing breast surgery.

You may qualify if:

  • Breast or axillary surgery

You may not qualify if:

  • Other diagnosed movement disorder
  • Cannot consent due to language or capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsMobility LimitationMotor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Richard Kwasnicki

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard M Kwasnicki, PhD MRCS

CONTACT

+44 (0) 20 759 48904rmk107@ic.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

April 23, 2018

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

GB(1)