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Clinical Trials/NCT06568978
NCT06568978
Completed
N/A

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

Istanbul University - Cerrahpasa (IUC)1 site in 1 country82 target enrollmentNovember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lymphedema of Upper Limb
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
82
Locations
1
Primary Endpoint
MIP and MEP value
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
August 20, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Gamze Aydin

Researcher, PhD

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

MIP and MEP value

Time Frame: 9 months

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

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.

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.

FVC

Time Frame: 9 months

FVC is used for forced vital capacity which measure by spirometer

pectoralis minor muscle length

Time Frame: 9 months

pectoralis minor muscle length is used for pectoralis muscle shortness

Study Sites (1)

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