CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Exercices +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04785599
NCT04785599N/ACompleted

Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·interventional·Posted Mar 8, 2021·Updated Mar 8, 2021

In Brief

A clinical study evaluating Exercices, Informative talk, and 1 other intervention for Lymphedema and 3 related conditions. Completed, enrolled 70 participants.

Detailed Summary

ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program. Methods: Clinical randomized trial in two parallel groups over a two-year period. Key words: lymphedema, breast cancer, prevention, rehabilitation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
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Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2021
Enrollment StartOct 3, 2011
Primary CompletionOct 3, 2011
Study CompletionApr 13, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 5.3 years ago

Interventions

Exercicesbehavioral

An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.

Informative talkbehavioral

An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center

Compression garmentdevice

Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.