.Exercise and Follow-up After a Mastectomy (mastectomy)

American University of Beirut Medical Center

Status: Completed

Conditions: Mastectomy; Lymphedema

Treatments: Behavioral: education

Study type: Interventional

Funder types: Other

Identifiers

NCT04184102

NU04

Details and patient eligibility

About

A Randomized Control Trial (RCT) on the effect of education and Exercise on women after a mastectomy found positive results in range of motion of the affected shoulder and quality of life in the intervention group.

Full description

Background: Breast cancer ranks highest in incidence and mortality among females and ranks second when both genders are combined. Lebanon has the second highest rate of breast cancer worldwide for the 35-39 age group and the highest in the 40-49 age group. Mastectomy often results in deceased shoulder and arm mobility, and decreased Quality of Life.

Objective: The objective of this study was to assess the effect of an educational program of therapeutic exercises on the quality of life and functional ability in women after a mastectomy Methods: Sixty women undergoing mastectomy were randomly assigned to an intervention and control group. The intervention group received extensive teaching pre-surgery education as well as training on therapeutic exercises. Follow up phone calls to the Intervention group were made to assure that the exercises were being done. Both groups were visited at home at four and eight to obtain the outcome variables. The Breast Cancer Patient Version was used to asses quality of life and the "Goniometer" was used to assess the range of motion of the affected shoulder.

Enrollment: 60 patients

Sex: Female

Ages: 33 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria included:

• women between 35 and 55 years of age
• diagnosed with breast cancer
• scheduled for modified radical mastectomy. .

Exclusion Criteria included:

• Women who were pregnant,
• not able to communicate,
• had co-morbidities that affected their QoL

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention exercise

Experimental group

Description:

The experimental group received education and exercise training before a mastectomy.

Treatment:

Behavioral: education

Control

No Intervention group

Description:

Received routine hospital care which did not include any exercise education