LymphedemaNCT00498771
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
A study testing Aquatic Exercise arm in people with Lymphedema, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Aquatic Exercise arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2013
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients with Lymphedema
- Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
- Patients undergoing treatment will require written permission from their physician
- Complete an assessment by a licensed physical therapist before beginning the exercise program
- Patients must sign a consent form to participate
- Men, women and minorities with breast cancer related lymphedema are eligible
Who cannot join
- Patients undergoing treatment without physician's written permission
- Patients with health problems that contraindicate exercise
- Patients are not eligible if the physical therapy assessment identifies a contraindication to participation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.
Read the detailed description
This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.
There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).
Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.
- Conditions
- Lymphedema
- Being tested
- Aquatic Exercise arm
- Keywords
- Lymphedema, Aquatic Exercise, Breast Cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Exercise armBehavioural
Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Exercise arm | Active comparator | Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month. Receives: Behavioral: Aquatic Exercise arm |
| Control - No Exercise Arm | No intervention | No exercise will be performed in Control arm. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL) at baseline, 6 week, 6 and 12 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Lymphedema
Comparison of the circumference and volumetric measurements of the affected limb will be made prior to, midpoint and at completion of the 12 class program. Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared
Measured: baseline, week 6, month 6, and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Grant, M.D., Principal investigator, Baylor Sammons Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498771
- Sponsor's protocol ID
- 006-116
- Status last verified
- Jun 2017
- First submitted
- 9 Jul 2007
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT00498771
- Acronym / sponsor ID
- 006-116
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Aquatic Exercise, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Jul 2007 (estimated)
- 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.
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.
Detailed description
This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.
There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).
Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercise arm | Active comparator | Behavioral: Aquatic Exercise armParticipants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month. |
| Control - No Exercise Arm | No intervention | –No exercise will be performed in Control arm. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL) at baseline, 6 week, 6 and 12 month. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Breast cancer patients with Lymphedema
- Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
- Patients undergoing treatment will require written permission from their physician
- Complete an assessment by a licensed physical therapist before beginning the exercise program
- Patients must sign a consent form to participate
Key exclusion criteria (3 listed)
- Patients undergoing treatment without physician's written permission
- Patients with health problems that contraindicate exercise
- Patients are not eligible if the physical therapy assessment identifies a contraindication to participation
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 |
|---|---|---|
| Aquatic Exercise armParticipants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference \& volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month. | Behavioural | Aquatic Exercise arm |
Primary outcome
Reduction of Lymphedema
Time frame: baseline, week 6, month 6, and month 12
Comparison of the circumference and volumetric measurements of the affected limb will be made prior to, midpoint and at completion of the 12 class program. Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared
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 12 Jun 2017.
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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.
Michael Grant, M.D. principal investigator
Baylor Sammons Breast Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercise arm in people with Lymphedema, run by Baylor Research Institute at 1 site in United States.
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 6 inclusion and 3 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 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Reduction of Lymphedema (time frame: baseline, week 6, month 6, and month 12). 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 12 Jun 2017.