Lymphedema
Conditions
Keywords
Resistance Exercise, Compression Therapy, Physical activity, Sedentary time, supervised exercise
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.
Interventions
OTHERResistance exercise
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Sponsors
Carsten Bogh Juhl
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Statistician will be blinded for group allocation
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower leg circumference | 14 days | circumferential sensor CIMON, measured in Picoferens (pF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Limb volume | 14 days | perometry, volume (mL) |
| Edema of the foot and ankle | 14 days | Figure of eight with tape measure, (cm) |
| Extracellular fluid of the lower limb | 14 days | Bioimpedance Spectroscophy, (L-dex) |
| Body composition | 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/%) |
| Segmental body composition of the lower limbs | 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) |
| Self reported lymphedema symptoms | 14 days | Pain, tension, heaviness, tinkling, numeric ranking scale 0-10 |
| Physical activity | 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 |
| Adverse events | 14 days | E.g. skin irritation, cellulitis, severe muscle injury, number of events |
| Adherence to compression | 14 days | Adherence to compression garments = 7 days a week, yes or no, if no - number of days with compression per participant |
| Adherence to study | 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 |
| Withdrawal from study | 8 weeks | Number of participants and reasons for withdrawal |
Countries
Denmark
Contacts
CONTACTMerete C Wittenkamp, PhD student
STUDY_CHAIRCarsten B Juhl, Professor
Herlev Gentofte Hospital
Outcome results
None listed