Clinical trial NCT05119049: Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.
Official title: Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental study randomized controlled
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of Aquatic Therapeutic Exercise by providing a set of exercises in the reduction and / or control the volume of secondary lymphedema treatment of breast cancer in patients who are in the maintenance phase of conventional treatment. It is an experimental, randomized, unifactorial, and intersubjective study. The intervention group will be treated by guided underwater exercises while the control group will receive the same set of exercises out-of-water. The research will be based on comparing the difference on the volume of lymphedema obtained by the exercises provided aquatic environment and out-of-water exercises. The study population will be obtained from rehabilitation service Bellvitge Hospital. The goal is to evaluate the volume of lymphedema and the quality of life related to the health of patients will be evaluated before starting the treatment, at the end of the 20 sessions, when the treatment reaches 3 months and when patient is discharged.

Detailed description: A randomized controlled experimental study has been carried out where two work groups were compared, experimental N: 43 that carried out an exercise regimen designed in the aquatic environment and control N: 47 that carried out the same regimen of exercises in a physiotherapy room. Both groups did 20 treatment sessions of 45 minutes duration with a frequency of 2 or 3 days per week. Lymphedema changes, quality of life and adherence to treatment were evaluated. The evaluations were 3 days prior to the start of the program, at the end of the 20 sessions, and at 3 months.

Eligibility criteria: Inclusion Criteria:

* Female gender.
* Age between 18 and 75 years.
* Diagnosis of lymphedema in the upper limb secondary to breast cancer treatment.
* Present mild lymphedema or moderate (types I and II respectively according to the volumetric classification of the types of edema according to severity).

Exclusion Criteria:

* Primary lymphedema or secondary to other surgery.
* Bilateral lymphedema.
* Presence of hydrophobia.
* Severe cardiovascular and respiratory diseases.
* Urinary and fecal incontinence.

Primary outcomes:
measure: Volume of the affected limb.
timeFrame: 3 days before the start of the program, at 30 days, and at 3 months after completing the sessions.
Secondary outcomes:
measure: Quality of life health related.
timeFrame: 3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
measure: Adherence
timeFrame: At 3 months after completing the sessions.
measure: Age.
timeFrame: 3 days before the start of the program.
measure: Severity of lymphedema
timeFrame: 3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
Other outcomes:
Locations:
Study officials:
affiliation: Bellvitge Hospital
name: Isabel López Zamora, physiotherapist
role: PRINCIPAL_INVESTIGATOR
References: