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

30. april 2026 opdateret af: Carsten Bogh Juhl

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Danmark
      • Herlev, Danmark, 2730
        • Rekruttering
        • Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
        • Kontakt:
        • Ledende efterforsker:
          • Merete Wittenkamp, PhD student

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: Resistance exercise
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Eksperimentel: 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
Andet: Resistance exercise
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Eksperimentel: 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
Andet: Resistance exercise
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lower leg circumference
Tidsramme: 14 days
circumferential sensor CIMON, measured in Picoferens (pF)
14 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lower Limb volume
Tidsramme: 14 days
perometry, volume (mL)
14 days
Lower Limb volume
Tidsramme: 14 days
circumferential measurements, 8 cm interval, converted to volume (mL)
14 days
Edema of the foot and ankle
Tidsramme: 14 days
Figure of eight with tape measure, (cm)
14 days
Extracellular fluid of the lower limb
Tidsramme: 14 days
Bioimpedance Spectroscophy, (L-dex)
14 days
Body composition
Tidsramme: 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/%)
14 days
Segmental body composition of the lower limbs
Tidsramme: 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)
14 days
Self reported lymphedema symptoms
Tidsramme: 14 days
Pain, tension, heaviness, tinkling, numeric ranking scale 0-10
14 days
Physical activity
Tidsramme: 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
14 days
Adverse events
Tidsramme: 14 days
E.g. skin irritation, cellulitis, severe muscle injury, number of events
14 days
Adherence to compression
Tidsramme: 14 days
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
Tidsramme: 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
8 weeks
Withdrawal from study
Tidsramme: 8 weeks
Number of participants and reasons for withdrawal
8 weeks
Adherence to study
Tidsramme: 8 weeks
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Carsten Bogh Juhl

Efterforskere

  • Studiestol: Carsten B Juhl, Professor, Herlev Gentofte Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

15. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LymphEx

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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