Clinical trial NCT06568978: Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema
Official title: Evaluation of Disease Severity, Respiratory Muscle Strength, Respiratory Functions, Functionality, and Quality of Life in Patients With Upper Limb Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema of Upper Limb
Keywords: Lymphedema
upper limb
quality of life
respiratory function test
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-08-23
Enrollment: 82
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged 25-65 years with secondary, unilateral upper limb lymphedema patients and healthy controls

Brief summary: The aim of our study is to assess disease severity, respiratory muscle strength, respiratory functions, pectoralis minor muscle shortening, functionality, and quality of life (QoL) in patients with upper limb lymphedema (ULL), and to compare these findings with healthy controls.The disease severity was assessed using the Stillwell classification system; respiratory muscle strength was measured through maximum inspiratory and expiratory intraoral pressures (MIP, MEP, respectively); respiratory functions were evaluated with a spirometer; pectoralis minor muscle shortening was measured with a tape measure; functionality was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH); and QoL was evaluated with the Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm).

Detailed description: The study had a cross-sectional observational study design. The participants were divided into two groups, patients with ULL in Group 1; the healthy individuals were included in Group 2. All assessments for both groups were performed by two different physiotherapists.

Eligibility criteria: Inclusion Criteria:

* aged 25-65 years with secondary, unilateral upper limb lymphedema in Phase 2 of the protection stage,
* wearing compression garments,
* who have not received manual lymph drainage (MLD) therapy in the last 3 months
* along with healthy controls of a similar age who volunteered to participate.

Exclusion Criteria:

* being in Phase 1 of lymphedema treatment (the edema-reducing phase),
* being classified as NYHA Class III and/or IV according to the New York Heart Association classification system,
* having a chronic respiratory disease,
* presence of active infection (such as lymphangitis or cellulitis), or undergoing radiotherapy/chemotherapy due to breast cancer.

Primary outcomes:
measure: MIP and MEP value
timeFrame: 9 months
measure: FVC
timeFrame: 9 months
measure: pectoralis minor muscle length
timeFrame: 9 months
measure: DASH questionnaire
timeFrame: 9 months
measure: LYMQOL-Arm questionnaire
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Gamze Aydın
state: İstanbul
Study officials:
affiliation: Okan University
name: Gamze Aydın, PhD
role: PRINCIPAL_INVESTIGATOR
References: