The Effects of Pre-operative Physical Therapy Education

NCT ID: NCT01669187

Last Updated: 2014-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education brochure

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

Group Type ACTIVE_COMPARATOR

Education brochure

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Live education and exercise instruction

Intervention Type 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.

Interventions

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Education brochure

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oakland University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Eve S Pepin, DPT

Role: PRINCIPAL_INVESTIGATOR

Oakland University

Locations

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St-Mary's of Michigan

Saginaw, Michigan, United States

Site Status

St. Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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OU-4824

Identifier Type: -

Identifier Source: org_study_id

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