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The Effects of Pre-operative Physical Therapy Education

This study is not yet open for participant recruitment.
Verified August 2012 by Oakland University
Sponsor:
Information provided by (Responsible Party):
Oakland University
ClinicalTrials.gov Identifier:
NCT01669187
First received: July 20, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669187

Contacts
Contact: Deborah Doherty, PhD doherty@oakland.edu

Locations
United States, Michigan
St. Mary's of Michigan Not yet recruiting
Saginaw, Michigan, United States, 48601
St-Mary's of Michigan Not yet recruiting
Saginaw, Michigan, United States, 48601
Sponsors and Collaborators
Oakland University
Investigators
Principal Investigator: Marie-Eve S Pepin, DPT Oakland University
  More Information

No publications provided

Responsible Party: Oakland University
ClinicalTrials.gov Identifier: NCT01669187     History of Changes
Other Study ID Numbers: OU-4824
Study First Received: July 20, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013