Lymphedema Cancer
Conditions
Interventions
This is a randomized controlled trial. Participants are randomly assigned (1:1) to intervention or control groups using a sequence generated via randomizer.org. The study includes several intervention
Sponsors
Provita Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years 2. Unilateral lymphedema of the upper or lower limb (stage I, II or III according to the clinical classification) 3. Diagnosis of secondary lymphedema (e.g. after oncological, surgical or post-traumatic treatment) 4. Stable clinical condition, without signs of acute inflammation at the site of the swelling 5. No contraindications to physiotherapy, compression therapy, pneumocompression or exercise testing 6. Ability to move independently and follow simple instructions of a physiotherapist 7. Consent to participate in the study expressed in writing after reading the informed consent form In the case of control groups: no active lymphedema and no history of treatment related to the swelling
Exclusion criteria
Exclusion criteria: 1. Diagnosed cardiovascular diseases, such as: heart failure, unstable hypertension (blood pressure >140/90 mmHg), thromboembolic disease 2. Active bacterial, viral or fungal infection in the limb affected by edema 3. Cancer during active treatment (chemotherapy, radiotherapy) or relapse of oncological disease 4. Edema of a non-lymphatic nature (e.g. varicose, renal, cardiogenic, lipid) 5. Open wounds, skin damage or inflammation in the areas of planned measurements or therapy application 6. Pregnancy or postpartum period 7. Neurological disorders affecting motor control (e.g. stroke, multiple sclerosis) 8. Psychiatric disorders that prevent informed consent and cooperation in the study 9. Use of painkillers or anti-inflammatory drugs less than 24 hours before measurement 10. Participation in another clinical trial in the last 30 days 11. Refusal to participate in the study or withdrawal of consent at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Muscle elasticity measured using shear wave elastography (Sonoscape P20, linear probe 5–20 MHz) at baseline, post-intervention, and at 1 week, 1 month, and 3 months 2. Limb volume assessed using: 2.1. Kuhnke method (manual circumference-based calculation) at baseline, post-intervention, and at 1 week, 1 month, and 3 months 2.2. Water volumetry (immersion tank, ±5 ml precision) at baseline, post-intervention, and at 1 week, 1 month, and 3 months 3. Muscle tone, stiffness, and elasticity measured by MyotonPRO (Hz, N/m, arbitrary units) at baseline, post-intervention, and at 1 week, 1 month, and 3 months 4. Isometric muscle strength measured with ForceDecks (kgf) at baseline and post-intervention. 5. Reactive strength index (RSI) measured with ForceDecks (m/s) at baseline and post-intervention. 6. Perfusion parameters measured using laser doppler flowmetry (PeriFlux 5000): resting flow, biological zero (BZ), time to biological zero (BZt), time to reperfusion (TR), maximal hyperemic peak (MHP) at baseline and follow-ups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle thickness measured using ultrasound (Sonoscape P20) at baseline and post-intervention 2. Perceived fatigue level measured using Borg RPE scale (6–20) before and after sessions 3. Perfusion parameters measured using laser Doppler flowmetry (LDF): time to return to baseline (TR), BZ/RF ratio at baseline and follow-ups 4. Motor preparation and recovery habits measured using a custom questionnaire once at baseline | — |
Countries
Germany, Poland
Contacts
Public ContactSmoter Malgorzta
Outcome results
None listed