Clinical trial NCT04184102: .Exercise and Follow-up After a Mastectomy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy; Lymphedema
Keywords: mastectomy
education
exercise
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 33
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to a control of experimental group by flipping a coin
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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

Primary outcomes:
measure: Measuring the range of motion of the affected shoulder at two weeks.
timeFrame: At 2 weeks after surgery
measure: Measuring the range of motion of the affected shoulder at four weeks.
timeFrame: At 4 weeks after surgery
measure: Assessing the quality of life of participants at two weeks
timeFrame: At two weeks after surgery
measure: Assessing the Quality of life of participants at four weeks
timeFrame: At 4 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University Medical Center (AUBMC)
Study officials:
affiliation: American University of Beirut Medical Center
name: Iman Kouatly, MpH
role: STUDY_DIRECTOR
References:
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citation: Majed M, Neimi CA, Youssef SM, Takey KA, Badr LK. The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, an RCT. J Cancer Educ. 2022 Jun;37(3):843-851. doi: 10.1007/s13187-020-01894-z. Epub 2020 Nov 20.