Skip to main content
OpenTrials
Completed

NCT Number: NCT07014566

Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema

This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Extremity Lymphedema

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University Hospital

Istanbul, Turkey (Türkiye)

About this study

This study evaluated the feasibility and effectiveness of a digital physiotherapy program based on combined decongestive therapy in patients with lower extremity lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital physiotherapy program with remote supervision. Compression stockings were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymphoedema functioning, disability and health questionnaire questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with unilateral lower extremity lymphedema (either primary or secondary)
  • Patients aged 18 years or older

Exclusion criteria

  • Presence of metastatic disease
  • History of coronary heart disease, pulmonary disease, or acute infection of any cause
  • Presence of peripheral neuropathy

Treatment and study plan

Digital Combined Decongestive Therapy

Other

The intervention consisted of a digitally delivered combined decongestive therapy (CDT) program for patients with unilateral or bilateral lower extremity lymphedema. Patients attended a single face-to-face session where a physiotherapist provided training on skin care, self-bandaging, self-manual lymphatic drainage, and therapeutic exercises (breathing, gluteal sets, knee sets, and toe movements). Caregivers recorded the demonstrations for home use. Following this session, a 4-week remote physiotherapy program was implemented using telecommunication technologies. Patients continued self-management with guidance via digital platforms. Compression stockings replaced self-bandaging during the 12-week follow-up phase.

Primary outcomes

  1. Change in Limb Volume

    Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)

    Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.

Secondary outcomes

  1. Change in Quality of Life

    Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)

    Quality of life was assessed using the Turkish version of the Lymphedema Functioning, Disability and Health Questionnaire (Lymph-ICF), which is specific to lymphedema. The scale consists of 29 items across five domains: physical function, mental function, household activities, mobility activities, and social life. Each item was scored on a 0-100 mm visual analog scale (VAS), where higher scores indicate greater impairment and reduced quality of life.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.