Lower Limb LymphedemaNCT06839885
Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema
A study testing Interventional group in people with Lower Limb Lymphedema and Unilateral Leg Edema, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Limb Lymphedema, Unilateral Leg Edema
- What is being tested?
- Interventional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary or secondary unilateral lower extremity lymphedema diagnosis
- Patients who have received at least 2 weeks of complex decongestive therapy in the past
- Patients who are cooperative with hydrotherapy treatments
- Patients who are willing to participate in the treatment
- Patients aged 18-75
Who cannot join
- Patients who are unable to perform the evaluation parameters
- Patients with serious systemic diseases that may prevent exercise
- Patients who have had an injury and/or surgery in the last 6 months
- Conditions where hydrotherapy is contraindicated (severe fear of water, behavioral problems, shortness of breath at rest, incontinence, known chlorine allergy, open wound, acute systemic illness, epilepsy, tracheostomy, permanent drain, immunodeficiency)
- Patients with an active infection anywhere in the body
- Patients who have undergone sentinel lymph node biopsy
- Patients with active metastatic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
GaziosmanpasaTREH
Istanbul
Serap Seringeç Karabulut, 05057242669, serapseringec@hotmail.com
About this study
Official title: Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema
Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. The gold standard in lymphedema treatment is complex decongestive therapy.Manual lymphatic drainage, skin care, the use of compression garments, and home exercise programs play an important role. Exercise therapies lead to a reduction in volume and an improvement in functionality and quality of life in patients with lymphedema. However, studies on this subject have mostly focused on upper extremity lymphedema. This study aims to compare the effects of a home exercise program and hydrotherapy combined with a home exercise program on quality of life, lower extremity functionality, exercise capacity, and edema severity in patients with unilateral lower extremity lymphedema
Read the detailed description
This study included patients, with in the control group and in the intervention group, who applied to the lymphedema outpatient clinic at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Therapy and Rehabilitation. The demographic and clinical data of the patients were recorded. Before treatment, limb volume was assessed using the circumference measurement method, quality of life was evaluated with the Lymphedema Quality of Life Questionnaire (LYMQOL), lower extremity functionality was assessed with the Lower Extremity Functional Scale (LEFS), and exercise capacity was measured using the 10-Meter Walk Test. Patients in the control group followed only a home exercise program for 6 weeks, while the intervention group received hydrotherapy combined with a home exercise program for the same period. Hydrotherapy was conducted as 30-minute aquatic exercise sessions in groups of 5-7 participants, in a hydrotherapy pool with a depth of 130 cm and a temperature of 30-31°C, under the supervision of a trained physiotherapist. At the end of the treatment, patients were re-evaluated in terms of volume, functionality, quality of life, and exercise capacity. The two groups were compared regarding volume measurement, functionality, and quality of life
- Conditions
- Lower Limb Lymphedema, Unilateral Leg Edema
- Being tested
- Interventional group, Control group
- Keywords
- Aerobic exercise, Hydrotherapy, Functionality, Gynecological cancer, Lymphedema, Exercise capacity, Quality of life
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional groupOther
Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the last year and completed treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. The patients were planned to be treated in the hydrotherapy unit during lunch breaks, under the supervision of a volunteer physiotherapist.
After the initial assessments, patients in the study group will perform aquatic exercises in groups of 5 or 7 participants, three times a week for 6 weeks, under the supervision of a physiotherapist.Patients in the intervention group will receive a home exercise program and self-drainage.
Control groupOther
Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the past year and completed their treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. Patients were planned to be treated in the hydrotherapy unit during lunch breaks under the supervision of a volunteer physiotherapist.
After the initial assessments, patients in the control group will receive a home exercise program and self-drainage.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the past year and completed their treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. Patients were planned to be treated in the hydrotherapy unit during lunch breaks under the supervision of a volunteer physiotherapist.
After the initial assessments, patients in the control group will receive a home exercise program and self-drainage. Receives: Other: Control group |
| Intervention Group | Experimental | Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the last year and completed treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. The patients were planned to be treated in the hydrotherapy unit during lunch breaks, under the supervision of a volunteer physiotherapist.
After the initial assessments, patients in the study group will perform aquatic exercises in groups of 5 or 7 participants, three times a week for 6 weeks, under the supervision of a physiotherapist. Patients in the intervention group will receive a home exercise program and self-drainage. Receives: Other: Interventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume measurement
Patients who applied to the lymphedema outpatient clinic had their leg circumference measurements taken before starting the treatment program and 6 weeks later, starting from the ankle (medial malleolus) and at 4 cm intervals up to the inguinal region. Using these measured data, an approximate volume calculation was made using the circumference (Frustum) method.
Measured: six weeks
Secondary outcomes (2)
Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)
The LYMQOL-leg questionnaire was used to assess the quality of life specific to lymphedema before and after treatment for all patients participating in the study. The questionnaires were administered through face-to-face interviews.
LYMQOL can be used in clinical assessments for patients with lymphedema, as well as in evaluating treatment outcomes. LYMQOL is a disease-specific quality of life scale for lymphedema patients. The LYMQOL questionnaire has two separate sections for evaluating the upper and lower extremities: LYMQOL-arm and LYMQOL-leg. The questions in the LYMQOL-leg questionnaire are related to 4 sections. This questionnaire consists of a total of 22 questions. Questions 1-3 assess function, questions 4-10 assess body image, questions 11-15 assess symptoms, questions 16-21 assess mood, and question 22 evaluates 'general quality of life.' The first 21 questions are scored on a scale of 1-4 (1 = none, 2 = a little, 3 = quite a bit, 4 = very much).
Measured: six weeks
Lower Extremity Functional Scale
The LEFS scale was used to assess the functional status of the lower extremities before and after treatment for all patients participating in the study. The questionnaires were administered through face-to-face interviews. The LEFS questionnaire, used to assess functional status in patients and consists of a total of 20 questions. Each question in the LEFS questionnaire is scored on a scale of 0 to 4 (0 - Extremely difficult or unable to do, 1 - Quite difficult, 2 - Moderately difficult, 3 - Slightly difficult, 4 - No difficulty). The total score ranges from 0 to 80. In the LEFS questionnaire, an increase in the score indicates an improvement in the patient's functional status. The Turkish reliability and validity of this questionnaire have been demonstrated in studies.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start15 Dec 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Limb 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
- two groups: an intervention group and a control group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Çiğdem Aşlı, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Yılmaz Yalçınkaya, Study director, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839885
- Sponsor's protocol ID
- GaziosmanpasaTREH-FTR-ÇA-001
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali KM, El Gammal ER, Eladl HM. Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. Ann Rehabil Med. 2021 Apr;45(2):131-140. doi: 10.5535/arm.20127. Epub 2021 Apr 14.
PubMed 33849087Dionne A, Goulet S, Leone M, Comtois AS. Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. J Altern Complement Med. 2018 Sep/Oct;24(9-10):1007-1009. doi: 10.1089/acm.2018.0041.
PubMed 30247973Yeung W, Semciw AI. Aquatic Therapy for People with Lymphedema: A Systematic Review and Meta-analysis. Lymphat Res Biol. 2018 Feb;16(1):9-19. doi: 10.1089/lrb.2016.0056. Epub 2017 Mar 27.
PubMed 28346851
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT06839885
- Acronym / sponsor ID
- GaziosmanpasaTREH-FTR-ÇA-001
- Conditions
- Lower Limb Lymphedema, Unilateral Leg Edema
- Keywords
- Aerobic exercise, Hydrotherapy, Functionality, Gynecological cancer, Lymphedema, Exercise capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. The gold standard in lymphedema treatment is complex decongestive therapy.Manual lymphatic drainage, skin care, the use of compression garments, and home exercise programs play an important role. Exercise therapies lead to a reduction in volume and an improvement in functionality and quality of life in patients with lymphedema. However, studies on this subject have mostly focused on upper extremity lymphedema. This study aims to compare the effects of a home exercise program and hydrotherapy combined with a home exercise program on quality of life, lower extremity functionality, exercise capacity, and edema severity in patients with unilateral lower extremity lymphedema
Detailed description
This study included patients, with in the control group and in the intervention group, who applied to the lymphedema outpatient clinic at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Therapy and Rehabilitation. The demographic and clinical data of the patients were recorded. Before treatment, limb volume was assessed using the circumference measurement method, quality of life was evaluated with the Lymphedema Quality of Life Questionnaire (LYMQOL), lower extremity functionality was assessed with the Lower Extremity Functional Scale (LEFS), and exercise capacity was measured using the 10-Meter Walk Test. Patients in the control group followed only a home exercise program for 6 weeks, while the intervention group received hydrotherapy combined with a home exercise program for the same period. Hydrotherapy was conducted as 30-minute aquatic exercise sessions in groups of 5-7 participants, in a hydrotherapy pool with a depth of 130 cm and a temperature of 30-31°C, under the supervision of a trained physiotherapist. At the end of the treatment, patients were re-evaluated in terms of volume, functionality, quality of life, and exercise capacity. The two groups were compared regarding volume measurement, functionality, and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups: an intervention group and a control group
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupPatients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the past year and completed their treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. Patients were planned to be treated in the hydrotherapy unit during lunch breaks under the supervision of a volunteer physiotherapist. After the initial assessments, patients in the control group will receive a home exercise program and self-drainage. |
| Intervention Group | Experimental | Other: Interventional groupPatients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the last year and completed treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. The patients were planned to be treated in the hydrotherapy unit during lunch breaks, under the supervision of a volunteer physiotherapist. After the initial assessments, patients in the study group will perform aquatic exercises in groups of 5 or 7 participants, three times a week for 6 weeks, under the supervision of a physiotherapist. Patients in the intervention group will receive a home exercise program and self-drainage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with primary or secondary unilateral lower extremity lymphedema diagnosis
- Patients who have received at least 2 weeks of complex decongestive therapy in the past
- Patients who are cooperative with hydrotherapy treatments
- Patients who are willing to participate in the treatment
- Patients aged 18-75
Key exclusion criteria (7 listed)
- Patients who are unable to perform the evaluation parameters
- Patients with serious systemic diseases that may prevent exercise
- Patients who have had an injury and/or surgery in the last 6 months
- Conditions where hydrotherapy is contraindicated (severe fear of water, behavioral problems, shortness of breath at rest, incontinence, known chlorine allergy, open wound, acute systemic illness, epilepsy, tracheostomy, permanent drain, immunodeficiency)
- Patients with an active infection anywhere in the body
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 |
|---|---|---|
| Interventional groupPatients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the last year and completed treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. The patients were planned to be treated in the hydrotherapy unit during lunch breaks, under the supervision of a volunteer physiotherapist. After the initial assessments, patients in the study group will perform aquatic exercises in groups of 5 or 7 participants, three times a week for 6 weeks, under the supervision of a physiotherapist.Patients in the intervention group will receive a home exercise program and self-drainage. | Other | Intervention Group |
| Control groupPatients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the past year and completed their treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. Patients were planned to be treated in the hydrotherapy unit during lunch breaks under the supervision of a volunteer physiotherapist. After the initial assessments, patients in the control group will receive a home exercise program and self-drainage. | Other | Control group |
Primary outcome
Volume measurement
Time frame: six weeks
Patients who applied to the lymphedema outpatient clinic had their leg circumference measurements taken before starting the treatment program and 6 weeks later, starting from the ankle (medial malleolus) and at 4 cm intervals up to the inguinal region. Using these measured data, an approximate volume calculation was made using the circumference (Frustum) method.
2 secondary outcomes
Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)
Time frame: six weeks
Lower Extremity Functional Scale
Time frame: six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 33849087Ali KM, El Gammal ER, Eladl HM. Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. Ann Rehabil Med. 2021 Apr;45(2):131-140. doi: 10.5535/arm.20127. Epub 2021 Apr 14.
- Background: PubMed 30247973Dionne A, Goulet S, Leone M, Comtois AS. Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. J Altern Complement Med. 2018 Sep/Oct;24(9-10):1007-1009. doi: 10.1089/acm.2018.0041.
- Background: PubMed 28346851Yeung W, Semciw AI. Aquatic Therapy for People with Lymphedema: A Systematic Review and Meta-analysis. Lymphat Res Biol. 2018 Feb;16(1):9-19. doi: 10.1089/lrb.2016.0056. Epub 2017 Mar 27.
- 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.
Ebru Yılmaz Yalçınkaya study director
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional group in people with Lower Limb Lymphedema and Unilateral Leg Edema, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevser Gümüşsu (05323628768, kevsergumussu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume measurement (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06839885, which also lists 3 linked publications.
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 21 Feb 2025.