Breast Cancer LymphedemaNCT05119049
Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.
A study testing Exercise guideline in people with Breast Cancer Lymphedema, run by Isabel Lopez Zamora.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Exercise guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Primary lymphedema or secondary to other surgery.
- Bilateral lymphedema.
- Presence of hydrophobia.
- Severe cardiovascular and respiratory diseases.
- Urinary and fecal incontinence.
About this study
Official title: Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.
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.
Read the 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
- Being tested
- Exercise guideline
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise guidelineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
FACT-B+4 scale: general physical wellbeing, family/social wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns.
Measured: 3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
Adherence
Rate of adherence to treatment. Adherence to treatment questionnaire: YES / NO
Measured: At 3 months after completing the sessions.
Age.
Possible influence of age and confounding factors.
Measured: 3 days before the start of the program.
Severity of lymphedema
Volume of limb. Possible influence and confounding factors.
Measured: 3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study startJan 2016
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study randomized controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabel Lopez Zamora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isabel Lopez Zamora, Hospital Universitari de Bellvitge
- Investigators
- Isabel López Zamora, physiotherapist, Principal investigator, Bellvitge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119049
- Sponsor's protocol ID
- ILZamora
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05119049
- Acronym / sponsor ID
- ILZamora
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Isabel Lopez ZamoraUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Experimental study randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercise plan in the pool. | Experimental | Other: Exercise guidelineThe experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department. |
| Exercises in a rehabilitation room. | Active comparator | Other: Exercise guidelineThe control group did the same exercises and sessions in one of the rooms in the rehabilitation department. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Primary lymphedema or secondary to other surgery.
- Bilateral lymphedema.
- Presence of hydrophobia.
- Severe cardiovascular and respiratory diseases.
- Urinary and fecal incontinence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise guidelineThe 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. | Other | Aquatic exercise plan in the pool., Exercises in a rehabilitation room. |
Primary outcome
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.
4 secondary outcomes
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.
Adherence
Time frame: At 3 months after completing the sessions.
Age.
Time frame: 3 days before the start of the program.
Severity of lymphedema
Time frame: 3 days before the start of the program, at 30 days and at 3 months after completing the sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel López Zamora, physiotherapist principal investigator
Bellvitge Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Exercise guideline in people with Breast Cancer Lymphedema, run by Isabel Lopez Zamora.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.