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Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema

Evaluation of Disease Severity, Respiratory Muscle Strength, Respiratory Functions, Functionality, and Quality of Life in Patients With Upper Limb Lymphedema

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06568978
Enrollment
82
Registered
2024-08-23
Start date
2023-11-20
Completion date
2024-08-20
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema, upper limb, quality of life, respiratory function test

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.

Interventions

OTHERAssessments of respiratory parameters

respiratory muscle strength, respiratory function test

Sponsors

Okan University
CollaboratorOTHER
Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
MIP and MEP value9 monthsassessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).
FVC9 monthsFVC is used for forced vital capacity which measure by spirometer
pectoralis minor muscle length9 monthspectoralis minor muscle length is used for pectoralis muscle shortness
DASH questionnaire9 monthsDisabilities of the Arm, Shoulder and Hand (DASH) is used for upper extremity functions. Questionnaire score ranged between 0-100. A higher total score indicates decreased functionality.
LYMQOL-Arm questionnaire9 monthsLymphedema Quality of Life Questionnaire - Arm is used for assess disease related quality of life.The high scores are indicative of poorer QoL. Questionnaire score ranged between 0-100.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026