The Effects of Pre-operative Physical Therapy Education

NCT01669187 | Withdrawn

• 1 other identifier: OU-4824
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in score for Shoulder Pain and Disability Index (SPADI)

  Functional outcome measure questionnaire

  Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively

Secondary Outcomes (1)

• Change in Shoulder range of motion with goniometer

  Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively

Other Outcomes (1)

• Change in other physical therapy test and measures

  Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery

Study Arms (2)

Education brochure

ACTIVE COMPARATOR

The control group will receive a standard education brochure which will be provided pre-operatively to the participants.

Other: Education brochure

Live education and exercise instruction

EXPERIMENTAL

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

Interventions

Education brochure OTHER

Education brochure

Live education and exercise instruction OTHER

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.

Live education and exercise instruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oakland University: lead

Study Sites (2)

St-Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

St. Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie-Eve S Pepin, DPT

  Oakland University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 20, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (2)