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

NCT07014566 | Completed

• 1 other identifier: Lenfödemalt2025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Extremity Lymphedema

Keywords

Lower extremity lymphedema; Digital physiotherapy; Combined decongestive therapy

Outcome Measures

Primary Outcomes (1)

• Change in Limb Volume

  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.

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

Secondary Outcomes (1)

• Change in Quality of Life

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

Study Arms (1)

Digital Combined Decongestive Therapy Group

EXPERIMENTAL

Patients received digital combined decongestive therapy, including self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care education, with remote supervision over 4 weeks, followed by a maintenance phase with compression stockings.

Other: Digital Combined Decongestive Therapy

Interventions

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.

Digital Combined Decongestive Therapy Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.

  PMID: 32402630 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: February 5, 2019
• Primary Completion: October 15, 2024
• Study Completion: November 22, 2024
• Last Updated: June 11, 2025

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)