The Effects of Pre-operative Physical Therapy Education

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Other: Education brochure; Other: Live education and exercise instruction

• Registration Number: NCT01669187
• Lead Sponsor: Oakland University

Brief Summary

It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• be over the age of 18,
• have a good understanding of the English language, and
• be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Exclusion Criteria

• if they previously underwent one of the previously mentioned procedures mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education brochure	Education brochure	The control group will receive a standard education brochure which will be provided pre-operatively to the participants.
Live education and exercise instruction	Live education and exercise instruction	The intervention group will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.

Primary Outcome Measures

Name	Time	Method
Change in score for Shoulder Pain and Disability Index (SPADI)	Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively	Functional outcome measure questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Shoulder range of motion with goniometer	Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively

Trial Locations

Locations (2)

St. Mary's of Michigan; 🇺🇸 Saginaw, Michigan, United States

St-Mary's of Michigan; 🇺🇸 Saginaw, Michigan, United States