Aerobic Exercise Effects in Lower Extremity Lymphedema
22 juillet 2026 mis à jour par: Sinem Akselim, Bursa Yuksek Ihtisas Training and Research Hospital
Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema
Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments.
To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sinem Akselim
- Numéro de téléphone: +905336391332
- E-mail: sinemakselim@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Diagnosis of lower extremity lymphedema (unilateral or bilateral)
- Age ≥18 years
- Absence of cognitive impairment
- Provision of written informed consent to participate in the study
Exclusion Criteria:
- Cognitive impairment
- Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris)
- Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program
- Presence of unhealed fractures in the lower extremities preventing exercise therapy
- Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities
- Acute venous thromboembolic events involving the lower extremities
- Heart failure or renal failure that may cause lower extremity edema
- Presence of concomitant lipedema
- Presence of venous insufficiency
- Ongoing chemotherapy or radiotherapy (among patients with malignancy-related lymphedema)
- Pregnancy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: control group
participants receive standart complete decongestive therapy including manuel lymph drainage,compression therapy, skin care and exercises
|
manuel lymph drainage, skin care, joint rom exercises, compression
|
|
Expérimental: exercise group
participants receive complete decongestive therapy combined with an aerobic exercise program
|
manuel lymph drainage, skin care, joint rom exercises, compression
Aerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve. The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Kinesiophobia
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Kinesiophobia will be assessed using the validated Turkish version of the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire with a total score ranging from 17 to 68.
Change in score from baseline to post-treatment will be evaluated.
Higher scores indicate greater kinesiophobia.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
All ultrasonographic measurements will be performed by the same experienced examiner under standardized conditions and will be assessed using B-mode ultrasonography. Quadriceps muscle thickness and subcutaneous tissue thickness will be assessed at standardized anatomical landmarks of the anterior thigh. Subcutaneous tissue thickness will be assessed at standardized anatomical sites of the lower limb. Measurements will be recorded in millimeters (mm). Greater thickness indicates increased muscle mass or subcutaneous tissue thickness, respectively. Change in muscle thickness from baseline to post-treatment will be evaluated. |
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Subcutaneous tissue echogenicity will be assessed by analyzing grayscale intensity values within a defined region of interest using B-mode ultrasonography.
Echogenicity will be quantified in grayscale values (arbitrary units).
Higher values indicate increased echogenicity.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
Balance
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Balance performance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure with a total score ranging from 0 to 56.
Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance.
Change in score from baseline to post-treatment will be evaluated.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
functional mobility
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down.
Change in time from baseline to post-treatment will be evaluated.
Higher times indicate poorer functional mobility.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
Lower limb functional status
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Lower limb functional status will be assessed using the Lower Limb Functional Index (LLFI), a 25-item patient-reported outcome measure with a total score ranging from 0 to 100.
Scores are typically expressed as a percentage, with higher scores indicating better functional status.
Change in score from baseline to post-treatment will be evaluated.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
fatigue
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-reported questionnaire with each item scored from 1 to 7. The total score is calculated as the mean of the items, ranging from 1 to 7, with higher scores indicating greater fatigue severity.
Change in score from baseline to post-treatment will be evaluated.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
depression
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Depression will be assessed using the Beck Depression Inventory (BDI), a 21-item self-reported questionnaire with a total score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Change in score from baseline to post-treatment will be evaluated.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
|
health related quality of life
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL), a disease-specific patient-reported outcome measure including domains such as function, appearance, symptoms, and mood.
Domain scores and overall score range from 0 to 10, with higher scores indicating worse quality of life.
Change in scores from baseline to post-treatment will be evaluated.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
functional capacity
Délai: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), which measures the distance walked in meters over 6 minutes.
Change in distance from baseline to post-treatment will be evaluated.
Greater distances indicate better functional performance.
|
baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
15 décembre 2026
Achèvement de l'étude (Estimé)
15 mars 2027
Dates d'inscription aux études
Première soumission
12 mars 2026
Première soumission répondant aux critères de contrôle qualité
22 juillet 2026
Première publication (Réel)
24 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2024-TBEK-2025/12-15
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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