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NCT Number: NCT05119049

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Volume of the affected limb.

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

    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.

Secondary outcomes

  1. Quality of life health related.

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

    FACT-B+4 scale: general physical wellbeing, family/social wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns.

  2. Adherence

    Time frame: At 3 months after completing the sessions.

    Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO

  3. Age.

    Time frame: 3 days before the start of the program.

    Possible influence of age and confounding factors.

  4. Severity of lymphedema

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

    Volume of limb. Possible influence and confounding factors.

Sponsors and collaborators

Lead sponsor

Isabel Lopez Zamora

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 12, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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