CClinicalTrials.gg
CompletedNCT00489125Updated Jun 4, 2019

Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer

An observational study in Breast Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2019-06-04.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
Up to 120 Years
Sex
Female
01

Study summary

RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.

PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.

Read the detailed description

OBJECTIVES:

  • Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.
  • Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.
  • Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.
  • Examine relationships between exercise participation, fitness, and body composition over time.
  • Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.

OUTLINE: This is a prospective, cohort study.

Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • long-term effects secondary to cancer therapy in adults
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 400 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any woman treated in the Breast Clinic of WFUBMC with a diagnosis of stage 0-IV breast cancer and identified as a candidate by their surgeon.

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of breast cancer

    • Stage I-IV disease
  • Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Interventions

  • Otherphysiologic testing

    physical testing of range of motion, grip strength etc.

06

What researchers measure

Primary outcomes

  1. Collection of data before surgery, at each follow-up visit, and at 2 years after surgery

    Time frame: approximately 2 years

  2. Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time

    Time frame: approximately 2 years

  3. Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy

    Time frame: approximately 2 years

  4. Relationships between exercise participation, fitness, and body composition over time

    Time frame: approximately 2 years

  5. Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures

    Time frame: approximately 2 years

07

Study locations

1 site
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00489125
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 21, 2007
Start date
Oct 15, 2004
Primary completion
Jul 20, 2018
Completion
Jul 20, 2018
Last update
Jun 4, 2019

Study contacts

Shannon Mihalko, PhD
principal investigator · Wake Forest University Health Sciences
Edward A. Levine, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion