LymphedemaNCT05426993
Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients
An observational study of Lymphedema, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Complex decongestive physiotherapy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Mar 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As a result of the power analysis made with the help of the preliminary study data using the G*Power 3.0.10 program; with 90% power, 5% margin of error and f=0.27 effect size, a total of at least 40 samples were found to be sufficient (metabolic syndrome group: 20; control group: 20). Patients diagnosed with lymphedema by a specialist in our clinic will be divided into 2 groups as those with metabolic syndrome and those without metabolic syndrome.
Who may be able to join
- Those between the ages of 18-65,
- To be diagnosed with lymphedema in the lower or upper extremities
- Volunteering to participate in the study
- Getting >24 points from the Standardized Mini mental test
Who cannot join
- Having a score of <24 on the Standardized Mini Mental Test
- Finding any problem preventing communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients
As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome.
Read the detailed description
This study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower and upper extremity lymphedema has been clearly demonstrated.
Metabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (BMI) is associated with the frequency and severity of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema.
Our aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of CDT.
- Conditions
- Lymphedema
- Being tested
- Complex decongestive physiotherapy
- Keywords
- lymphedema, metabolic syndrome
- Medical subject headings
- Lymphedema, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive physiotherapyOther
CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with lymphedema with metabolic syndrome | Demographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made.
As a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks. Receives: Other: Complex decongestive physiotherapy | |
| Patients diagnosed with lymphedema without metabolic syndrome | Demographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made.
As a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks. Receives: Other: Complex decongestive physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb volume
Edema evaluation will be made for the lower extremity from the lateral malleolus to the groin at 4 cm intervals. For the upper extremity, it will be made from the styloid process of the ulna to the axilla at intervals of 4 cm. The extremity volume will be determined from the values obtained with the help of the Frustrum formula.
Measured: 15.09.2022
Secondary outcomes (1)
Life quality
Quality of life will be evaluated with the Lymphedema Quality of Life Scale used routinely. This assessment, which was validated by Borman et al., consists of 21 questions under the sub-titles of Function, Body Image, Symptom, and Emotion. Scoring between 1 and 4 is made for the first 20 questions. The total score for each area is calculated by adding all the scores and dividing by the total number of questions answered. High scores indicate lower quality of life. The last question about overall quality of life is scored from 0 to 10. Higher scores indicate better quality of life
Measured: 15.12.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 Jul 2022
- Primary completion15 Sep 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426993
- Sponsor's protocol ID
- E2-22-1805
- Status last verified
- Dec 2023
- First submitted
- 16 Jun 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pirincci CS, Mete O, Yasa ME, Dalyan M. A comparative evaluation of the efficacy of complete decongestive therapy in the treatment of unilateral breast cancer-related lymphedema with and without metabolic syndrome. Support Care Cancer. 2024 Jun 29;32(7):473. doi: 10.1007/s00520-024-08676-z.
PubMed 38949715
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients
- ClinicalTrials.gov ID
- NCT05426993
- Acronym / sponsor ID
- E2-22-1805
- Conditions
- Lymphedema
- Keywords
- lymphedema, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 22 Jun 2022 (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.
As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome.
Detailed description
This study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower and upper extremity lymphedema has been clearly demonstrated.
Metabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (BMI) is associated with the frequency and severity of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema.
Our aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of CDT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with lymphedema with metabolic syndrome | – | Other: Complex decongestive physiotherapyDemographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made. As a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks. |
| Patients diagnosed with lymphedema without metabolic syndrome | – | Other: Complex decongestive physiotherapyDemographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made. As a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As a result of the power analysis made with the help of the preliminary study data using the G*Power 3.0.10 program; with 90% power, 5% margin of error and f=0.27 effect size, a total of at least 40 samples were found to be sufficient (metabolic syndrome group: 20; control group: 20). Patients diagnosed with lymphedema by a specialist in our clinic will be divided into 2 groups as those with metabolic syndrome and those without metabolic syndrome.
Key inclusion criteria (4 listed)
- Those between the ages of 18-65,
- To be diagnosed with lymphedema in the lower or upper extremities
- Volunteering to participate in the study
- Getting >24 points from the Standardized Mini mental test
Key exclusion criteria (2 listed)
- Having a score of <24 on the Standardized Mini Mental Test
- Finding any problem preventing communication
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 |
|---|---|---|
| Complex decongestive physiotherapyCDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. | Other | Patients diagnosed with lymphedema with metabolic syndrome, Patients diagnosed with lymphedema without metabolic syndrome |
Primary outcome
Limb volume
Time frame: 15.09.2022
Edema evaluation will be made for the lower extremity from the lateral malleolus to the groin at 4 cm intervals. For the upper extremity, it will be made from the styloid process of the ulna to the axilla at intervals of 4 cm. The extremity volume will be determined from the values obtained with the help of the Frustrum formula.
1 secondary outcome
Life quality
Time frame: 15.12.2022
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 4 Dec 2023.
- Derived from this study: PubMed 38949715Pirincci CS, Mete O, Yasa ME, Dalyan M. A comparative evaluation of the efficacy of complete decongestive therapy in the treatment of unilateral breast cancer-related lymphedema with and without metabolic syndrome. Support Care Cancer. 2024 Jun 29;32(7):473. doi: 10.1007/s00520-024-08676-z.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Gulhane School of Medicine 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 2 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 4 Dec 2023. 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?
Limb volume (time frame: 15.09.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426993, which also lists 1 linked publication.
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 4 Dec 2023.