Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema

NCT ID: NCT06568978

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-08-20

Brief Summary

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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

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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.

Conditions

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Lymphedema of Upper Limb

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

patients with upper limb lymphedema

Assessments of respiratory parameters

Intervention Type OTHER

respiratory muscle strength, respiratory function test

Group 2

healthy individuals

Assessments of respiratory parameters

Intervention Type OTHER

respiratory muscle strength, respiratory function test

Interventions

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Assessments of respiratory parameters

respiratory muscle strength, respiratory function test

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Okan University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Gamze Aydin

Researcher, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamze Aydın, PhD

Role: PRINCIPAL_INVESTIGATOR

Okan University

Locations

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Gamze Aydın

Tuzla, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IstanbulOU

Identifier Type: -

Identifier Source: org_study_id

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