Clinical trial NCT05426993: Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients
Official title: Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Keywords: lymphedema
metabolic syndrome
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Having a score of \<24 on the Standardized Mini Mental Test
* Finding any problem preventing communication

Primary outcomes:
measure: Limb volume
timeFrame: 15.09.2022
Secondary outcomes:
measure: Life quality
timeFrame: 15.12.2022
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
Study officials:
References: