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

NCT ID: NCT07014566

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2024-11-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lower Extremity Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Combined Decongestive Therapy Group

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.

Group Type EXPERIMENTAL

Digital Combined Decongestive Therapy

Intervention Type 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.

Interventions

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Digital Combined Decongestive Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Selva Otsay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bezmialem Vakıf University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32402630 (View on PubMed)

Other Identifiers

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Lenfödemalt2025

Identifier Type: -

Identifier Source: org_study_id

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