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Completed

NCT Number: NCT00489125

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 120 year

Sex eligibility

Female

Study type

Observational

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiologic Testing

Other

physical testing of range of motion, grip strength etc.

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Breast Clinic Strength and Range of Motion Study

Important dates

Study start
2004
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2007
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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