Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema
August 22, 2024 updated by: Gamze Aydin, Istanbul University - Cerrahpasa (IUC)
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İstanbul
-
Tuzla, İstanbul, Turkey, 34940
- Gamze Aydın
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
patients with upper limb lymphedema
|
respiratory muscle strength, respiratory function test
|
|
Group 2
healthy individuals
|
respiratory muscle strength, respiratory function test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MIP and MEP value
Time Frame: 9 months
|
assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).
|
9 months
|
|
FVC
Time Frame: 9 months
|
FVC is used for forced vital capacity which measure by spirometer
|
9 months
|
|
pectoralis minor muscle length
Time Frame: 9 months
|
pectoralis minor muscle length is used for pectoralis muscle shortness
|
9 months
|
|
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.
|
9 months
|
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gamze Aydın, PhD, Okan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.