Skip to main content
OpenTrials
Completed

NCT Number: NCT06568978

Evaluation of Respiratory Parameters 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema of Upper Limb Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

25 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Gamze Aydın

Tuzla, Istanbul, 34940, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessments of respiratory parameters

Other

respiratory muscle strength, respiratory function test

Primary outcomes

  1. MIP and MEP value

    Time frame: 9 months

    assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).

  2. FVC

    Time frame: 9 months

    FVC is used for forced vital capacity which measure by spirometer

  3. pectoralis minor muscle length

    Time frame: 9 months

    pectoralis minor muscle length is used for pectoralis muscle shortness

  4. DASH questionnaire

    Time frame: 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.

  5. LYMQOL-Arm questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Okan University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.