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

Breast Cancer Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119049
• Other study ID #: ILZamora
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2019

Study information

• Verified date: November 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isabel Lopez Zamora

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Adherence	Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO	At 3 months after completing the sessions.
Secondary	Age.	Possible influence of age and confounding factors.	3 days before the start of the program.
Secondary	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.