LymphedemaLymphExNCT07558317
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
A study testing Resistance exercise in people with Lymphedema, run by Carsten Bogh Juhl at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the short-term (within 2 weeks) effects of resistance exercise with and without compression garments on lower limb lymphedema(LLL). Additionally, the study will explore the immediate response in LLL to resistance exercise (2 hours and 24 hours post-exercise). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 5 May 2026to 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
- verified diagnosis of lymphedema of the lower limb
- completed compression bandaging
- adherence to compression garment in daytime (minumum 5-6 days per week)
- calf circumference > 35 and <75 cm
Who cannot join
- severe neuropathy of the lower leg
- severe skin problems or wounds at the lower leg
- cellulitis, DVT or acute injuries of the lower limb < 2 months prior to inclusion
- ongoing adjuvant treatment for cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
Herlev, 2730
Merete Wittenkamp, PhDstudent, 4593911784, merete.celano.wittenkamp@regionh.dk
Merete Wittenkamp, PhD student
About this study
Official title: The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema - With and With-out Compression - a Randomized Controlled Trial (the LymphEx Study)
The aim of the study is to investigate the short-term (within 2 weeks) effects of resistance exercise with and without compression garments on lower limb lymphedema(LLL). Additionally, the study will explore the immediate response in LLL to resistance exercise (2 hours and 24 hours post-exercise).
Participants will continously wear a circumfencential sensor at the calf (CIMON from Icompression) under a compression garment and an activity tracker (SENS Motion from SENS Innovation Aps) at the thigh for 3 periods (two with supervised exercise sessions of 2 weeks and one control period).
Participants will attend supervised resistance exercise 2-3 times per week for 2 periods of 2 weeks (one with compression garment and one without). Assessments with the principal investigator will be scheduled before and after every 2 week period. Participants will keep a digital diary or diary in paper of their lymphedema related symptoms and experienced issues with the sensors or app.
- Conditions
- Lymphedema
- Being tested
- Resistance exercise
- Keywords
- Resistance Exercise, Compression Therapy, Physical activity, Sedentary time, supervised exercise
- Medical subject headings
- Lymphedema, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Week 1-2 no exercise, week 3 washout, week 4-5 exercise without compression, week 6 washout, week 7-8 exercise with compression Receives: Other: Resistance exercise |
| Group B | Experimental | Week 1-2 exercise without compression, week 3 washout, week 4-5 exercise with compression, week 6 washout, week 7-8 no exercise Receives: Other: Resistance exercise |
| Group C | Experimental | Week 1-2 exercise with compression, week 3 washout, weekend 4-5 no exercise, week 6 washout, week 7-8 exercise without compression Receives: Other: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower leg circumference
circumferential sensor CIMON, measured in Picoferens (pF)
Measured: 14 days
Secondary outcomes (13)
Lower Limb volume
perometry, volume (mL)
Measured: 14 days
Lower Limb volume
circumferential measurements, 8 cm interval, converted to volume (mL)
Measured: 14 days
Edema of the foot and ankle
Figure of eight with tape measure, (cm)
Measured: 14 days
Extracellular fluid of the lower limb
Bioimpedance Spectroscophy, (L-dex)
Measured: 14 days
Body composition
Bioimpedance Spectroscophy, One measurement provides the following data: Total Body Water (L/%) , Extracellular fluid (L/%), Intracellular fluid (L/%), Skeletal muscle mass (kg/%), Fat mass (kg/%), Fat free mass (kg/%)
Measured: 14 days
Segmental body composition of the lower limbs
Bioimpedence Spectroscophy, One measurement provides the following data: Total Body water (L), Extracellular fluid (L), Intracellular fluid (L), Skeletal Muscle Mass(kg), Lean soft tissue (kg)
Measured: 14 days
Self reported lymphedema symptoms
Pain, tension, heaviness, tinkling, numeric ranking scale 0-10
Measured: 14 days
Physical activity
Daily number of minutes in activity (defined as the sum of time spent with standing, walking, cycling and high intensity activity) registered by a activity sensor (SENS Motion). Level of physical activity time per 24 hours at the following categories: lying, sitting, standing, walking, brisk walking, biking, high intensity activity
Measured: 14 days
Adverse events
E.g. skin irritation, cellulitis, severe muscle injury, number of events
Measured: 14 days
Adherence to compression
Adherence to compression garments = 7 days a week, yes or no, if no - number of days with compression per participant
Measured: 14 days
Adherence to study
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied per participant
Measured: 8 weeks
Withdrawal from study
Number of participants and reasons for withdrawal
Measured: 8 weeks
Adherence to study
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start5 May 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to three groups (group A, group B or group C) sequence between three period of two weeks with intervention (exercise + compression and exercise without compression) and no intervention will differ between groups. Washout period between each period will constitute of one week.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Bogh Juhl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carsten Bogh Juhl, Herlev and Gentofte Hospital
- Investigators
- Carsten B Juhl, Professor, Study chair, Herlev Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558317
- Sponsor's protocol ID
- LymphEx
- Acronym
- LymphEx
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema - With and With-out Compression - a Randomized Controlled Trial (the LymphEx Study)
- ClinicalTrials.gov ID
- NCT07558317
- Acronym / sponsor ID
- LymphEx / LymphEx
- Conditions
- Lymphedema
- Keywords
- Resistance Exercise, Compression Therapy, Physical activity, Sedentary time, supervised exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Carsten Bogh JuhlUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Apr 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.
The aim of the study is to investigate the short-term (within 2 weeks) effects of resistance exercise with and without compression garments on lower limb lymphedema(LLL). Additionally, the study will explore the immediate response in LLL to resistance exercise (2 hours and 24 hours post-exercise).
Participants will continously wear a circumfencential sensor at the calf (CIMON from Icompression) under a compression garment and an activity tracker (SENS Motion from SENS Innovation Aps) at the thigh for 3 periods (two with supervised exercise sessions of 2 weeks and one control period).
Participants will attend supervised resistance exercise 2-3 times per week for 2 periods of 2 weeks (one with compression garment and one without). Assessments with the principal investigator will be scheduled before and after every 2 week period. Participants will keep a digital diary or diary in paper of their lymphedema related symptoms and experienced issues with the sensors or app.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized to three groups (group A, group B or group C) sequence between three period of two weeks with intervention (exercise + compression and exercise without compression) and no intervention will differ between groups. Washout period between each period will constitute of one week.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Resistance exerciseWeek 1-2 no exercise, week 3 washout, week 4-5 exercise without compression, week 6 washout, week 7-8 exercise with compression |
| Group B | Experimental | Other: Resistance exerciseWeek 1-2 exercise without compression, week 3 washout, week 4-5 exercise with compression, week 6 washout, week 7-8 no exercise |
| Group C | Experimental | Other: Resistance exerciseWeek 1-2 exercise with compression, week 3 washout, weekend 4-5 no exercise, week 6 washout, week 7-8 exercise without compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- verified diagnosis of lymphedema of the lower limb
- completed compression bandaging
- adherence to compression garment in daytime (minumum 5-6 days per week)
- calf circumference > 35 and <75 cm
Key exclusion criteria (4 listed)
- severe neuropathy of the lower leg
- severe skin problems or wounds at the lower leg
- cellulitis, DVT or acute injuries of the lower limb < 2 months prior to inclusion
- ongoing adjuvant treatment for cancer
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 |
|---|---|---|
| Resistance exerciseSupervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM | Other | Group A, Group B, Group C |
Primary outcome
Lower leg circumference
Time frame: 14 days
circumferential sensor CIMON, measured in Picoferens (pF)
13 secondary outcomes
Lower Limb volume
Time frame: 14 days
Lower Limb volume
Time frame: 14 days
Edema of the foot and ankle
Time frame: 14 days
Extracellular fluid of the lower limb
Time frame: 14 days
Body composition
Time frame: 14 days
Segmental body composition of the lower limbs
Time frame: 14 days
Self reported lymphedema symptoms
Time frame: 14 days
Physical activity
Time frame: 14 days
Adverse events
Time frame: 14 days
Adherence to compression
Time frame: 14 days
Adherence to study
Time frame: 8 weeks
Withdrawal from study
Time frame: 8 weeks
Adherence to study
Time frame: 8 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 18 Sep 2026.
- 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.
Carsten B Juhl, Professor study chair
Herlev Gentofte 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 Resistance exercise in people with Lymphedema, run by Carsten Bogh Juhl at 1 site in Denmark.
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 4 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 18 Sep 2026. 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 Denmark. 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 Merete C Wittenkamp, PhD student (93911784, merete.celano.wittenkamp@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower leg circumference (time frame: 14 days). 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 18 Sep 2026.