We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Pre-operative Physical Therapy Education

This study has been withdrawn prior to enrollment.
(Study withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669187
First Posted: August 20, 2012
Last Update Posted: April 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oakland University
  Purpose
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.

Condition Intervention
Breast Cancer Other: Education brochure Other: Live education and exercise instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 of the The Effects of Pre-operative Physical Therapy Education and Exercise on Patient Outcomes Post Breast Cancer Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Oakland University:

Primary Outcome Measures:
  • Change in score for Shoulder Pain and Disability Index (SPADI) [ Time Frame: Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively ]
    Functional outcome measure questionnaire


Secondary Outcome Measures:
  • Change in Shoulder range of motion with goniometer [ Time Frame: Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively ]

Other Outcome Measures:
  • Change in other physical therapy test and measures [ Time Frame: Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery ]
    6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale.


Enrollment: 0
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Education brochure
The control group will receive a standard education brochure which will be provided pre-operatively to the participants.
Other: Education brochure
Experimental: 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.
Other: Live education and exercise instruction
Participants 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669187


Locations
United States, Michigan
St-Mary's of Michigan
Saginaw, Michigan, United States, 48601
St. Mary's of Michigan
Saginaw, Michigan, United States, 48601
Sponsors and Collaborators
Oakland University
Investigators
Principal Investigator: Marie-Eve S Pepin, DPT Oakland University
  More Information

Responsible Party: Oakland University
ClinicalTrials.gov Identifier: NCT01669187     History of Changes
Other Study ID Numbers: OU-4824
First Submitted: July 20, 2012
First Posted: August 20, 2012
Last Update Posted: April 10, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases