Clinical trial NCT05776433: The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life
Official title: The Effects of Extremity With Lymphedema on Posture, Upper Extremity Functions, and Quality of Life in Patients With Lymphedema After Unilateral Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Related Lymphedema
Breast Cancer-Related Arm Lymphedema
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: 10 minutes
measure: Lymphedema Functionality, Disability, and Health Questionnaire (Lymph-ICF)
timeFrame: 10 minutes
measure: Upper Extremity Lymphedema-27 (ULL-27)
timeFrame: 10 minutes
measure: Quality of Life Measure for Limb Lymphedema-Arm (LYMQOL-Arm)
timeFrame: 10 minutes
measure: The New York Posture Analysis (NYPA)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
measure: Upper Extremity Circumference Measurement
timeFrame: 1 hour
measure: Goniometric Measurements
timeFrame: 1 hour
Locations:
city: Kadıköy
country: Turkey
facility: Dr. Nazif Bağrıaçık Kadıköy Hospital
state: İstanbul
Study officials:
affiliation: Yeditepe University
name: Simla Turan
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University
name: Feryal Subaşı
role: STUDY_DIRECTOR
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