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The Effects of Pre-operative Physical Therapy Education

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01669187
Enrollment
0
Registered
2012-08-20
Start date
2011-12-31
Completion date
2012-12-31
Last updated
2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHERLive 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.

Sponsors

Oakland University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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-operativelyFunctional outcome measure questionnaire

Secondary

MeasureTime frame
Change in Shoulder range of motion with goniometerPre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively

Other

MeasureTime frameDescription
Change in other physical therapy test and measuresOnce pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery6 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026