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

NCT05119049 | Completed

• 1 other identifier: ILZamora
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life health related.

  3 days before the start of the program, at 30 days and at 3 months after completing the sessions.

• Adherence

  At 3 months after completing the sessions.

• Age.

  3 days before the start of the program.

• Severity of lymphedema

  3 days before the start of the program, at 30 days and at 3 months after completing the sessions.

Study Arms (2)

Aquatic exercise plan in the pool.

EXPERIMENTAL

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

Other: Exercise guideline

Exercises in a rehabilitation room.

ACTIVE COMPARATOR

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

Other: Exercise guideline

Interventions

Exercise guideline 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.

Aquatic exercise plan in the pool.; Exercises in a rehabilitation room.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Isabel Lopez Zamora: lead

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel López Zamora, physiotherapist

  Bellvitge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The initial, intermediate and final evaluations were carried out by a blind researcher, not familiar with the group assigned to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Experimental study randomized controlled

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 12, 2021
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share