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

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise guideline
Sponsored by
Isabel Lopez Zamora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Aquatic exercise plan in the pool.

    Exercises in a rehabilitation room.

    Arm Description

    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 and sessions in one of the rooms in the rehabilitation department.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Quality of life health related.
    FACT-B+4 scale: general physical wellbeing, family/social wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns.
    Adherence
    Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO
    Age.
    Possible influence of age and confounding factors.
    Severity of lymphedema
    Volume of limb. Possible influence and confounding factors.

    Full Information

    First Posted
    October 23, 2021
    Last Updated
    November 16, 2021
    Sponsor
    Isabel Lopez Zamora
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05119049
    Brief Title
    Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.
    Official Title
    Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    February 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Isabel Lopez Zamora

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Lymphedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Experimental study randomized controlled
    Masking
    Investigator
    Masking Description
    The initial, intermediate and final evaluations were carried out by a blind researcher, not familiar with the group assigned to the patients.
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aquatic exercise plan in the pool.
    Arm Type
    Experimental
    Arm Description
    The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department.
    Arm Title
    Exercises in a rehabilitation room.
    Arm Type
    Active Comparator
    Arm Description
    The control group did the same exercises and sessions in one of the rooms in the rehabilitation department.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise guideline
    Intervention Description
    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 Outcome Measure Information:
    Title
    Volume of the affected limb.
    Description
    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.
    Time Frame
    3 days before the start of the program, at 30 days, and at 3 months after completing the sessions.
    Secondary Outcome Measure Information:
    Title
    Quality of life health related.
    Description
    FACT-B+4 scale: general physical wellbeing, family/social wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns.
    Time Frame
    3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
    Title
    Adherence
    Description
    Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO
    Time Frame
    At 3 months after completing the sessions.
    Title
    Age.
    Description
    Possible influence of age and confounding factors.
    Time Frame
    3 days before the start of the program.
    Title
    Severity of lymphedema
    Description
    Volume of limb. Possible influence and confounding factors.
    Time Frame
    3 days before the start of the program, at 30 days and at 3 months after completing the sessions.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Isabel López Zamora, physiotherapist
    Organizational Affiliation
    Bellvitge Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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