Lymphedema of Upper LimbNCT06568978
Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema
An observational study of Lymphedema of Upper Limb, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- Assessments of respiratory parameters
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: aged 25-65 years with secondary, unilateral upper limb lymphedema patients and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- Assessments of respiratory parameters
- Keywords
- Lymphedema, upper limb, quality of life, respiratory function test
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments of respiratory parametersOther
respiratory muscle strength, respiratory function test
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with upper limb lymphedema Receives: Other: Assessments of respiratory parameters | |
| Group 2 | healthy individuals Receives: Other: Assessments of respiratory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIP and MEP value
assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).
Measured: 9 months
FVC
FVC is used for forced vital capacity which measure by spirometer
Measured: 9 months
pectoralis minor muscle length
pectoralis minor muscle length is used for pectoralis muscle shortness
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start20 Nov 2023
- Primary completion20 Jun 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Gamze Aydin, Istanbul University - Cerrahpasa
- Investigators
- Gamze Aydın, PhD, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568978
- Sponsor's protocol ID
- IstanbulOU
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Disease Severity, Respiratory Muscle Strength, Respiratory Functions, Functionality, and Quality of Life in Patients With Upper Limb Lymphedema
- ClinicalTrials.gov ID
- NCT06568978
- Acronym / sponsor ID
- IstanbulOU
- Conditions
- Lymphedema of Upper Limb
- Keywords
- Lymphedema, upper limb, quality of life, respiratory function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Assessments of respiratory parameterspatients with upper limb lymphedema |
| Group 2 | – | Other: Assessments of respiratory parametershealthy individuals |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aged 25-65 years with secondary, unilateral upper limb lymphedema patients and healthy controls
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessments of respiratory parametersrespiratory muscle strength, respiratory function test | Other | Group 1, Group 2 |
Primary outcome
MIP and MEP value
Time frame: 9 months
assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Aydın, PhD principal investigator
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema of Upper Limb, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIP and MEP value (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.