Skip to main content
OpenTrials
Completed

NCT Number: NCT04184102

.Exercise and Follow-up After a Mastectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mastectomy; Lymphedema Behavior Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Motor Activity

Age range

33 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American University Medical Center (AUBMC)

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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.

Other names: Exercise Modeling

Primary outcomes

  1. Measuring the range of motion of the affected shoulder at two weeks.

    Time frame: At 2 weeks after surgery

    Measurement of shoulder range of motion using a Goniometer at two time points. The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy. The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint. Normal values are abduction: 150 degrees. adduction: 30 degrees, orward flexion: 150-180 degrees, Extension: 45-60 degrees and rotation (test with elbow flexed to 90 degrees). The "Goniometer" is a nonintrusive and the most commonly used method to assess the ROM of a joint due to its simplicity and ease to implement The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy.The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint.

  2. Measuring the range of motion of the affected shoulder at four weeks.

    Time frame: At 4 weeks after surgery

    Measurement of shoulder range of motion using a Goniometer at two time points. The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy. The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint. Normal values are abduction: 150 degrees. adduction: 30 degrees, orward flexion: 150-180 degrees, Extension: 45-60 degrees and rotation (test with elbow flexed to 90 degrees). The "Goniometer" is a nonintrusive and the most commonly used method to assess the ROM of a joint due to its simplicity and ease to implement The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy.The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint.

  3. Assessing the quality of life of participants at two weeks

    Time frame: At two weeks after surgery

    Qaulity of lfe was assessed at points in time. The Quality of Life Instrument: The Breast Cancer Patient Version (QoL-BC) was used to asses QoL. The QoL-BC is a patient self-reported scale assessing concerns of cancer survivors.It includes 46 items assessing four domains: 1) physical well-being (8 items), 2) psychological well-being, (22 items), 3) social well-being,(9 items) and 4) spiritual well-being (7 items). The itmes are scored form 0 to 10, 0 = worst outcome to 10 = best outcome. Several items have reverse anchors and therefore when you code the items you will need to reverse the scores of those items. Higher scores indicate better outocme.The overall and the subscales instrument have shown excellent internal and external reliability and moderate to strong validity.The QoL-BC has been translated to Arabic and used with breast cancer patients in several Arab countries with good reliability and validity.

  4. Assessing the Quality of life of participants at four weeks

    Time frame: At 4 weeks after surgery

    Qaulity of lfe was assessed at points in time. The Quality of Life Instrument: The Breast Cancer Patient Version (QoL-BC) was used to asses QoL. The QoL-BC is a patient self-reported scale assessing concerns of cancer survivors.It includes 46 items assessing four domains: 1) physical well-being (8 items), 2) psychological well-being, (22 items), 3) social well-being,(9 items) and 4) spiritual well-being (7 items). The itmes are scored form 0 to 10, 0 = worst outcome to 10 = best outcome. Several items have reverse anchors and therefore when you code the items you will need to reverse the scores of those items. Higher scores indicate better outocme.The overall and the subscales instrument have shown excellent internal and external reliability and moderate to strong validity.The QoL-BC has been translated to Arabic and used with breast cancer patients in several Arab countries with good reliability and validity.

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study 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)

Acronym: mastectomy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2019
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.