The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study) (LymphEx)

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Other: Resistance exercise

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merete C Wittenkamp, PhD student; Phone Number: 93911784; Email: merete.celano.wittenkamp@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
    • Contact: Merete Wittenkamp, PhDstudent; Phone Number: 4593911784; Email: merete.celano.wittenkamp@regionh.dk
    • Principal Investigator: Merete Wittenkamp, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Week 1-2 no exercise, week 3 washout, week 4-5 exercise without compression, week 6 washout, week 7-8 exercise with compression	Other: Resistance exercise; Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Experimental: Group B; Week 1-2 exercise without compression, week 3 washout, week 4-5 exercise with compression, week 6 washout, week 7-8 no exercise	Other: Resistance exercise; Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Experimental: Group C; Week 1-2 exercise with compression, week 3 washout, weekend 4-5 no exercise, week 6 washout, week 7-8 exercise without compression	Other: Resistance exercise; Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower leg circumference	circumferential sensor CIMON, measured in Picoferens (pF)	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Limb volume	perometry, volume (mL)	14 days
Lower Limb volume	circumferential measurements, 8 cm interval, converted to volume (mL)	14 days
Edema of the foot and ankle	Figure of eight with tape measure, (cm)	14 days
Extracellular fluid of the lower limb	Bioimpedance Spectroscophy, (L-dex)	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/%)	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)	14 days
Self reported lymphedema symptoms	Pain, tension, heaviness, tinkling, numeric ranking scale 0-10	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	14 days
Adverse events	E.g. skin irritation, cellulitis, severe muscle injury, number of events	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	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	8 weeks
Withdrawal from study	Number of participants and reasons for withdrawal	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	8 weeks

Collaborators and Investigators

• Sponsor: Carsten Bogh Juhl
• Investigators: Study Chair: Carsten B Juhl, Professor, Herlev Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical activity; Resistance Exercise; supervised exercise; Compression Therapy; Sedentary time
• Additional Relevant MeSH Terms: Lymphatic Diseases; Behavior; Hemic and Lymphatic Diseases; Lymphedema; Motor Activity; Sedentary Behavior; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: LymphEx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No