Breast Clinic Strength and Range of Motion Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Collection of data before surgery, at each follow-up visit, and at 2 years after surgery
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 120 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Collection of data before surgery, at each follow-up visit, and at 2 years after surgery
Time Frame: approximately 2 years
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
Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy
Time Frame: approximately 2 years
Relationships between exercise participation, fitness, and body composition over time
Time Frame: approximately 2 years
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
Secondary Outcomes
No secondary outcomes reported