NCT07558317

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Mar 2027

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 15, 2026

Last Update Submit

April 30, 2026

Conditions

Lymphedema

Keywords

Resistance ExerciseCompression TherapyPhysical activitySedentary timesupervised exercise

Outcome Measures

Primary Outcomes (1)

  • Lower leg circumference

    circumferential sensor CIMON, measured in Picoferens (pF)

    14 days

Secondary Outcomes (13)

  • Lower Limb volume

    14 days

  • Lower Limb volume

    14 days

  • Edema of the foot and ankle

    14 days

  • Extracellular fluid of the lower limb

    14 days

  • Body composition

    14 days

  • +8 more secondary outcomes

Study Arms (3)

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

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

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

Other: Resistance exercise

Interventions

Resistance exerciseOTHER

Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM

Group AGroup BGroup C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe neuropathy of the lower leg
  • severe skin problems or wounds at the lower leg
  • ongoing adjuvant treatment for cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

LymphedemaMotor ActivitySedentary Behavior

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carsten B Juhl, Professor

    Herlev Gentofte Hospital

    STUDY CHAIR

Central Study Contacts

Merete C Wittenkamp, PhD student

CONTACT

93911784merete.celano.wittenkamp@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statistician will be blinded for group allocation
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)