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

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).

Study Overview

• Status: Completed
• Conditions: Lymphedema of Upper Limb
• Intervention / Treatment: Other: Assessments of respiratory parameters

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Tuzla, İstanbul, Turkey, 34940
      • Gamze Aydın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

aged 25-65 years with secondary, unilateral upper limb lymphedema patients and healthy controls

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; patients with upper limb lymphedema	Other: Assessments of respiratory parameters; respiratory muscle strength, respiratory function test
Group 2; healthy individuals	Other: Assessments of respiratory parameters; respiratory muscle strength, respiratory function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIP and MEP value	assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).	9 months
FVC	FVC is used for forced vital capacity which measure by spirometer	9 months
pectoralis minor muscle length	pectoralis minor muscle length is used for pectoralis muscle shortness	9 months
DASH questionnaire	Disabilities 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.	9 months
LYMQOL-Arm questionnaire	Lymphedema 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.	9 months

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Okan University
• Investigators: Principal Investigator: Gamze Aydın, PhD, Okan University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Lymphedema; quality of life; upper limb; respiratory function test
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: IstanbulOU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No