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Completed

NCT Number: NCT05426993

Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex decongestive physiotherapy

Other

CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Life quality

    Time frame: 15.12.2022

    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

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 22, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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