Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema

Completed

• Conditions: Lymphedema of Upper Limb
• Interventions: Other: Assessments of respiratory parameters

• Registration Number: NCT06568978
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Study Timeline

• Study Start: 2023-11-20
• Primary Completion: 2024-06-20
• Status Verified: 2024-08
• Study Completion: 2024-08-20
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Assessments of respiratory parameters	patients with upper limb lymphedema
Group 2	Assessments of respiratory parameters	healthy individuals

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gamze Aydın; 🇹🇷 Tuzla, İstanbul, Turkey