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

NCT05426993 | Completed

• 1 other identifier: E2-22-1805
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

lymphedema; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Life quality

  15.12.2022

Study Arms (2)

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

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

Interventions

Complex decongestive physiotherapy OTHER

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

Patients diagnosed with lymphedema with metabolic syndrome; Patients diagnosed with lymphedema without metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

University of Health Sciences

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38949715 DERIVED

MeSH Terms

Conditions

Lymphedema; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocc. Prof.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: March 15, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)