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
About this trial
This is an interventional treatment trial for Breast Cancer Lymphedema
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.
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
NCT ID
NCT05119049
First Posted
October 23, 2021
Last Updated
November 16, 2021
Sponsor
Isabel Lopez Zamora
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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