Lower Extremity LymphedemaNCT07726277
Aerobic Exercise Effects in Lower Extremity Lymphedema
A study testing aerobic exercise program and complet decongestive therapy in people with Lower Extremity Lymphedema, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- aerobic exercise program and complet decongestive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 15 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lower extremity lymphedema (unilateral or bilateral)
- Age ≥18 years
- Absence of cognitive impairment
- Provision of written informed consent to participate in the study
Who cannot join
- Cognitive impairment
- Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris)
- Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program
- Presence of unhealed fractures in the lower extremities preventing exercise therapy
- Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities
- Acute venous thromboembolic events involving the lower extremities
Show all 11Show fewer
- Heart failure or renal failure that may cause lower extremity edema
- Presence of concomitant lipedema
- Presence of venous insufficiency
- Ongoing chemotherapy or radiotherapy (among patients with malignancy-related lymphedema)
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema
Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments.
To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.
- Conditions
- Lower Extremity Lymphedema
- Being tested
- aerobic exercise program, complet decongestive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise programBehavioural
Aerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve.
The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions).
complet decongestive therapyOther
manuel lymph drainage, skin care, joint rom exercises, compression
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | participants receive standart complete decongestive therapy including manuel lymph drainage,compression therapy, skin care and exercises Receives: Other: complet decongestive therapy |
| exercise group | Experimental | participants receive complete decongestive therapy combined with an aerobic exercise program Receives: Behavioral: aerobic exercise program; Other: complet decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Kinesiophobia will be assessed using the validated Turkish version of the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire with a total score ranging from 17 to 68. Change in score from baseline to post-treatment will be evaluated. Higher scores indicate greater kinesiophobia.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness
All ultrasonographic measurements will be performed by the same experienced examiner under standardized conditions and will be assessed using B-mode ultrasonography.
Quadriceps muscle thickness and subcutaneous tissue thickness will be assessed at standardized anatomical landmarks of the anterior thigh. Subcutaneous tissue thickness will be assessed at standardized anatomical sites of the lower limb. Measurements will be recorded in millimeters (mm). Greater thickness indicates increased muscle mass or subcutaneous tissue thickness, respectively. Change in muscle thickness from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity
Subcutaneous tissue echogenicity will be assessed by analyzing grayscale intensity values within a defined region of interest using B-mode ultrasonography. Echogenicity will be quantified in grayscale values (arbitrary units). Higher values indicate increased echogenicity.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Balance
Balance performance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure with a total score ranging from 0 to 56. Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance. Change in score from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
functional mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down. Change in time from baseline to post-treatment will be evaluated. Higher times indicate poorer functional mobility.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Lower limb functional status
Lower limb functional status will be assessed using the Lower Limb Functional Index (LLFI), a 25-item patient-reported outcome measure with a total score ranging from 0 to 100. Scores are typically expressed as a percentage, with higher scores indicating better functional status. Change in score from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Secondary outcomes (3)
fatigue
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-reported questionnaire with each item scored from 1 to 7. The total score is calculated as the mean of the items, ranging from 1 to 7, with higher scores indicating greater fatigue severity. Change in score from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
depression
Depression will be assessed using the Beck Depression Inventory (BDI), a 21-item self-reported questionnaire with a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms. Change in score from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
health related quality of life
Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL), a disease-specific patient-reported outcome measure including domains such as function, appearance, symptoms, and mood. Domain scores and overall score range from 0 to 10, with higher scores indicating worse quality of life. Change in scores from baseline to post-treatment will be evaluated.
Measured: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sinem Akselim, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726277
- Sponsor's protocol ID
- 2024-TBEK-2025/12-15
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT07726277
- Acronym / sponsor ID
- 2024-TBEK-2025/12-15
- Conditions
- Lower Extremity Lymphedema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments.
To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: complet decongestive therapyparticipants receive standart complete decongestive therapy including manuel lymph drainage,compression therapy, skin care and exercises |
| exercise group | Experimental | Behavioral: aerobic exercise program, Other: complet decongestive therapyparticipants receive complete decongestive therapy combined with an aerobic exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of lower extremity lymphedema (unilateral or bilateral)
- Age ≥18 years
- Absence of cognitive impairment
- Provision of written informed consent to participate in the study
Key exclusion criteria (11 listed)
- Cognitive impairment
- Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris)
- Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program
- Presence of unhealed fractures in the lower extremities preventing exercise therapy
- Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities
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 |
|---|---|---|
| aerobic exercise programAerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve. The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions). | Behavioural | exercise group |
| complet decongestive therapymanuel lymph drainage, skin care, joint rom exercises, compression | Other | control group, exercise group |
Primary outcome
Kinesiophobia
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Kinesiophobia will be assessed using the validated Turkish version of the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire with a total score ranging from 17 to 68. Change in score from baseline to post-treatment will be evaluated. Higher scores indicate greater kinesiophobia.
musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
All ultrasonographic measurements will be performed by the same experienced examiner under standardized conditions and will be assessed using B-mode ultrasonography. Quadriceps muscle thickness and subcutaneous tissue thickness will be assessed at standardized anatomical landmarks of the anterior thigh. Subcutaneous tissue thickness will be assessed at standardized anatomical sites of the lower limb. Measurements will be recorded in millimeters (mm). Greater thickness indicates increased muscle mass or subcutaneous tissue thickness, respectively. Change in muscle thickness from baseline to post-treatment will be evaluated.
musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Subcutaneous tissue echogenicity will be assessed by analyzing grayscale intensity values within a defined region of interest using B-mode ultrasonography. Echogenicity will be quantified in grayscale values (arbitrary units). Higher values indicate increased echogenicity.
Balance
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Balance performance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure with a total score ranging from 0 to 56. Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance. Change in score from baseline to post-treatment will be evaluated.
functional mobility
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down. Change in time from baseline to post-treatment will be evaluated. Higher times indicate poorer functional mobility.
Lower limb functional status
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Lower limb functional status will be assessed using the Lower Limb Functional Index (LLFI), a 25-item patient-reported outcome measure with a total score ranging from 0 to 100. Scores are typically expressed as a percentage, with higher scores indicating better functional status. Change in score from baseline to post-treatment will be evaluated.
3 secondary outcomes
fatigue
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
depression
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
health related quality of life
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 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 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Lower Extremity Lymphedema
Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
Lymphedema
Recruiting
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy
RecruitingEarly Phase 1
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Lower Extremity Lymphedema
Recruiting
Boosted Compression for Lower Limb Chronic Edema
Chronic Edema, Lymphedema
Recruiting
Respiratory and Relaxation Training in Lower Extremity Lymphedema
Lower Extremity Lymphedema
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.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise program and complet decongestive therapy in people with Lower Extremity Lymphedema, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 11 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: opening soon, as of the sponsor's last update on 24 Jul 2026. 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?
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 Sinem Akselim (+905336391332, sinemakselim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)). The study lists 6 primary outcomes in all. 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 Jul 2026.