Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
Herlev, 2730, Denmark
Location status: Recruiting
Location contact
Merete Wittenkamp, PhD student
PRINCIPAL_INVESTIGATOR
Merete Wittenkamp, PhDstudent
CONTACT
Recruiting
NCT Number: NCT07558317
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Resistance Exercise
OtherSupervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Primary outcomes
-
Lower leg circumference
Time frame: 14 days
circumferential sensor CIMON, measured in Picoferens (pF)
Secondary outcomes
-
Lower Limb volume
Time frame: 14 days
perometry, volume (mL)
-
Lower Limb volume
Time frame: 14 days
circumferential measurements, 8 cm interval, converted to volume (mL)
-
Edema of the foot and ankle
Time frame: 14 days
Figure of eight with tape measure, (cm)
-
Extracellular fluid of the lower limb
Time frame: 14 days
Bioimpedance Spectroscophy, (L-dex)
-
Body composition
Time frame: 14 days
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/%)
-
Segmental body composition of the lower limbs
Time frame: 14 days
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)
-
Self reported lymphedema symptoms
Time frame: 14 days
Pain, tension, heaviness, tinkling, numeric ranking scale 0-10
-
Physical activity
Time frame: 14 days
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
-
Adverse events
Time frame: 14 days
E.g. skin irritation, cellulitis, severe muscle injury, number of events
-
Adherence to compression
Time frame: 14 days
Adherence to compression garments = 7 days a week, yes or no, if no - number of days with compression per participant
-
Adherence to study
Time frame: 8 weeks
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied per participant
-
Withdrawal from study
Time frame: 8 weeks
Number of participants and reasons for withdrawal
-
Adherence to study
Time frame: 8 weeks
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Carsten Bogh Juhl
Other
Registry information
Official study title
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema - With and With-out Compression - a Randomized Controlled Trial (the LymphEx Study)
Acronym: LymphEx
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 30, 2026
- Registry last updated
- May 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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