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

NCT ID: NCT05119049

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-02-28

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.

Conditions

Breast Cancer Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aquatic exercise plan in the pool.

The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department.

Group Type: EXPERIMENTAL

Exercise guideline

Intervention Type: OTHER

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.

Exercises in a rehabilitation room.

The control group did the same exercises and sessions in one of the rooms in the rehabilitation department.

Group Type: ACTIVE_COMPARATOR

Exercise guideline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Isabel Lopez Zamora

OTHER

Sponsor Role: lead

Responsible Party

Isabel Lopez Zamora

Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabel López Zamora, physiotherapist

Role: PRINCIPAL_INVESTIGATOR

Bellvitge Hospital

Other Identifiers

ILZamora

Identifier Type: -

Identifier Source: org_study_id