The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life

March 16, 2023 updated by: Simla Turan, Yeditepe University

The Effects of Extremity With Lymphedema on Posture, Upper Extremity Functions, and Quality of Life in Patients With Lymphedema After Unilateral Breast Cancer

This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).

The hypotheses of our study:

Hypothesis 0 (H0):

There is no relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.

Hypothesis 1 (H1):

There is a relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Kadıköy, İstanbul, Turkey, 34734
        • Dr. Nazif Bağrıaçık Kadıköy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The sample of the study consists of patients who applied to Istanbul Dr Nazif Bağrıaçık Kadıköy Hospital in Istanbul between May 2022 and October 2022 and were diagnosed with upper extremity lymphedema after unilateral breast cancer by the doctor.

Description

Inclusion Criteria:

  • Volunteering to participate in the research
  • Be between the ages of 18-50
  • Having had unilateral breast cancer
  • At least one year since breast cancer treatment
  • No active metastases

Exclusion Criteria:

  • Arthritis
  • Fibromyalgia syndrome
  • Neurological diseases
  • Mental illnesses
  • Myopathic diseases
  • Bilateral upper extremity lymphedema
  • Inability to communicate and cooperate
  • Presence of any orthopaedic disease in the affected upper extremity
  • Having scoliosis
  • Having cognitive problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Unilateral upper extremity lymphedema women after breast cancer treatment
The study group consisted of women aged 18-50 years with unilateral upper extremity lymphedema after breast cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time Frame: 10 minutes
It is a disability/symptom scoring system based on a self-report system of 30 items developed to evaluate upper extremity-specific physical functions and symptoms. The DASH questionnaire, which consists of three parts, contains 30 questions. Of these, 21 questions evaluate the patient's difficulty during physical activity, five assess symptoms (pain, activity-related pain, tingling, weakness, difficulty in movement), and the remaining four evaluate the patient's social function, work, sleep, and self-confidence. Questions are scored from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: none at all). The total score is between 0-100. The DASH score is calculated using the formula [sum of answers/n-1] x 25 (n=number of questions answered).
10 minutes
Lymphedema Functionality, Disability, and Health Questionnaire (Lymph-ICF)
Time Frame: 10 minutes
Lymph-ICF, a descriptive and evaluation tool, consists of 29 questions about the functional impairments, activity limitations, and participation restrictions reported by patients with breast cancer-related lymphedema. Physical function, mental function, home activities, mobility activities, and life and social activities are the five main components into which the questionnaire is subdivided. There is a visual analogue scale next to each question, and the patient marks the answer that suits themself. While calculating the survey score, the score of each subsection is found by summing and dividing by the number of questions answered. The total score is obtained by adding the scores of the subsections. A high score indicates that the effect on the quality of life is high.
10 minutes
Upper Extremity Lymphedema-27 (ULL-27)
Time Frame: 10 minutes
ULL-27 is a quality-of-life questionnaire evaluating upper extremity lymphedema as three components. The scale deals with physical, psychological and social components and consists of 27 questions. A 5-point Likert score (1=strongly disagree, 5=strongly agree) is used in the scale. The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. The lowest score is 27, and the highest score is 135. A high score on the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions, and this score of the person is between min 15 and 75. The psychological score consists of seven questions, with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum of 5 and a maximum of 25 points.
10 minutes
Quality of Life Measure for Limb Lymphedema-Arm (LYMQOL-Arm)
Time Frame: 10 minutes
The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.
10 minutes
The New York Posture Analysis (NYPA)
Time Frame: 5 minutes
Posture is the optimal form of all body parts about the whole body and the adjacent segment. This assessment test evaluates posture disorders that occur in 13 different body regions. The scoring of the test is as follows; A score of 5 is given if the person has a proper posture, 3 points if there is a moderate impairment, and 1 point if there is a severe disorder. The maximum score obtained at the end of the test is 65, and the minimum is 13. The standard evaluation criteria developed for the test are as follows for the total score; >=45: very good, 40-44: good, 30-39: medium, 20-29: weak, <=19:bad
5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Circumference Measurement
Time Frame: 1 hour
Circumference measurements were evaluated for both upper extremities. Markings were made every 4 cm, assuming the wrist pivot point. Upper extremity circumference measurements were made at 4 cm intervals up to the axilla. The difference between the affected and healthy sides was determined.
1 hour
Goniometric Measurements
Time Frame: 1 hour
The active range of motion (ROM) of both shoulders (affected and healthy) was measured with a goniometer. Flexion and abduction were measured in the supine position and extension in the prone position. Internal and external rotations were measured in the supine position with the shoulder 90° abducted and the elbow 90° flexion. A difference of ≥20° between the affected and unaffected sides was considered a limitation in the ROM of the affected side.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Investigators

  • Principal Investigator: Simla Turan, Yeditepe University
  • Study Director: Feryal Subaşı, Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YU-FTR-ST-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Related Lymphedema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe