NCT04184102

.Exercise and Follow-up After a Mastectomy

The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, a Randomized Control Trial (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: Female
• Age: 33 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Mastectomy; Lymphedema

Interventions

Type	Name	Description
BEHAVIORAL	education	The intervention group received pre-surgery education and training on therapeutic exercises in addition to the routine hospital care. The educational material was developed by the principal investigator (PI) and included a power point and a booklet with instructions on the exercises as well as information about the surgery and what to expect after the surgery. The educational material was based on previous research and adopted to our population after consultation with a panel of experts including two nurses and three physicians. Eligible women were approached while waiting for their appointment with their surgeon. If they showed interest in participating they signed a consent form. The PI explained the study and what is involved in participating including the weekly phone calls for women in the intervention group. Participants were told that they will visited at home by the PI to assess their ROM and to fill out a questionnaire.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-05-01
• Completion: 2018-07-30
• First posted: 2019-12-03
• Last updated: 2019-12-03

Locations

1 site across 1 country: Lebanon