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.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Merete C Wittenkamp, PhD student
- Telefonnummer: 93911784
- E-post: merete.celano.wittenkamp@regionh.dk
Studieorter
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Herlev, Danmark, 2730
- Rekrytering
- Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
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Kontakt:
- Merete Wittenkamp, PhDstudent
- Telefonnummer: 4593911784
- E-post: merete.celano.wittenkamp@regionh.dk
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Huvudutredare:
- Merete Wittenkamp, PhD student
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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 |
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM |
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Experimentell: 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 |
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM |
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Experimentell: 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 |
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Lower leg circumference
Tidsram: 14 days
|
circumferential sensor CIMON, measured in Picoferens (pF) |
14 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lower Limb volume
Tidsram: 14 days
|
perometry, volume (mL) |
14 days
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Lower Limb volume
Tidsram: 14 days
|
circumferential measurements, 8 cm interval, converted to volume (mL) |
14 days
|
|
Edema of the foot and ankle
Tidsram: 14 days
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Figure of eight with tape measure, (cm) |
14 days
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Extracellular fluid of the lower limb
Tidsram: 14 days
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Bioimpedance Spectroscophy, (L-dex) |
14 days
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Body composition
Tidsram: 14 days
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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
|
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Segmental body composition of the lower limbs
Tidsram: 14 days
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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
|
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Self reported lymphedema symptoms
Tidsram: 14 days
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Pain, tension, heaviness, tinkling, numeric ranking scale 0-10 |
14 days
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Physical activity
Tidsram: 14 days
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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
Tidsram: 14 days
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E.g. skin irritation, cellulitis, severe muscle injury, number of events |
14 days
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Adherence to compression
Tidsram: 14 days
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Adherence to compression garments = 7 days a week, yes or no, if no - number of days with compression per participant |
14 days
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Adherence to study
Tidsram: 8 weeks
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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
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Withdrawal from study
Tidsram: 8 weeks
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Number of participants and reasons for withdrawal |
8 weeks
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Adherence to study
Tidsram: 8 weeks
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Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied |
8 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Carsten B Juhl, Professor, Herlev Gentofte Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Lymfatiska sjukdomar
- Beteende
- Hemiska och lymfsjukdomar
- Lymfödem
- Motorisk aktivitet
- Stillasittande beteende
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Fysioterapimetoder
- Patientvård
- Träningsterapi
- Rehabilitering
- Eftervård
- Kontinuitet i patientvård
- Fysisk konditionering, mänsklig
- Utöva
- Motståndsträning
Andra studie-ID-nummer
- LymphEx
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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