Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema

NCT06568978 | Completed

• 1 other identifier: IstanbulOU
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphedema of Upper Limb

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group 1

patients with upper limb lymphedema

Other: Assessments of respiratory parameters

Group 2

healthy individuals

Other: Assessments of respiratory parameters

Interventions

Assessments of respiratory parameters OTHER

respiratory muscle strength, respiratory function test

Group 1; Group 2

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Okan University: collaborator

Study Sites (1)

Gamze Aydın

Tuzla, Istanbul, 34940, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gamze Aydın, PhD

  Okan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: November 20, 2023
• Primary Completion: June 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

TU (1)