Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Other: Complex decongestive physiotherapy

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Complex decongestive physiotherapy; CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.
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.	Other: Complex decongestive physiotherapy; CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15.09.2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15.12.2022

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: metabolic syndrome; lymphedema
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Lymphatic Diseases; Insulin Resistance; Hyperinsulinism; Lymphedema; Metabolic Syndrome
• Other Study ID Numbers: E2-22-1805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No