Health TrialsbyHealthPanel

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

ConditionLymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarsten Bogh Juhl

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Resistance exercise

    Other intervention

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

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lower leg circumference

circumferential sensor CIMON, measured in Picoferens (pF)

Time frame
14 days

Secondary outcomes

1

Lower Limb volume

perometry, volume (mL)

Time frame
14 days
2

Lower Limb volume

circumferential measurements, 8 cm interval, converted to volume (mL)

Time frame
14 days
3

Edema of the foot and ankle

Figure of eight with tape measure, (cm)

Time frame
14 days
4

Extracellular fluid of the lower limb

Bioimpedance Spectroscophy, (L-dex)

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carsten Bogh Juhl

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Source ClinicalTrials.gov
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