Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.

Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Other: Exercise guideline

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquatic exercise plan in the pool.; The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department.	Other: Exercise guideline; The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department. The control group did the same exercises in one of the rooms in the rehabilitation department, with the same number of sessions. Both groups were guided by a physiotherapist. The main outcome variables were assessed at the start of the study, at the end of the 20 sessions, and at 3 months after completing the sessions.
Active Comparator: Exercises in a rehabilitation room.; The control group did the same exercises and sessions in one of the rooms in the rehabilitation department.	Other: Exercise guideline; The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department. The control group did the same exercises in one of the rooms in the rehabilitation department, with the same number of sessions. Both groups were guided by a physiotherapist. The main outcome variables were assessed at the start of the study, at the end of the 20 sessions, and at 3 months after completing the sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of the affected limb.	The investigators assessed changes in the volume of the affected limb over a specified period of time and possible long-term improvements. The independent variable studied was the effect of exercise in water compared with exercise out of water. The expected outcome (dependent variable) was a reduction or maintenance of the volume of the lymphedema-affected limb. A measuring tape was used to take serial circumferential measurements of both limbs using anatomical reference points on both sides.	3 days before the start of the program, at 30 days, and at 3 months after completing the sessions.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life health related.	FACT-B+4 scale: general physical wellbeing, family/social wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns.	3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
Adherence	Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO	At 3 months after completing the sessions.
Age.	Possible influence of age and confounding factors.	3 days before the start of the program.
Severity of lymphedema	Volume of limb. Possible influence and confounding factors.	3 days before the start of the program, at 30 days and at 3 months after completing the sessions.

Collaborators and Investigators

• Sponsor: Isabel Lopez Zamora
• Investigators: Principal Investigator: Isabel López Zamora, physiotherapist, Bellvitge Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: ILZamora

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No