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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy
Herlev, Denmark
RECRUITINGLower leg circumference
circumferential sensor CIMON, measured in Picoferens (pF)
Time frame: 14 days
Lower Limb volume
perometry, volume (mL)
Time frame: 14 days
Lower Limb volume
circumferential measurements, 8 cm interval, converted to volume (mL)
Time frame: 14 days
Edema of the foot and ankle
Figure of eight with tape measure, (cm)
Time frame: 14 days
Extracellular fluid of the lower limb
Bioimpedance Spectroscophy, (L-dex)
Time frame: 14 days
Body composition
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/%)
Time frame: 14 days
Segmental body composition of the lower limbs
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)
Time frame: 14 days
Self reported lymphedema symptoms
Pain, tension, heaviness, tinkling, numeric ranking scale 0-10
Time frame: 14 days
Physical activity
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
Time frame: 14 days
Adverse events
E.g. skin irritation, cellulitis, severe muscle injury, number of events
Time frame: 14 days
Adherence to compression
Adherence to compression garments = 7 days a week, yes or no, if no - number of days with compression per participant
Time frame: 14 days
Adherence to study
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied per participant
Time frame: 8 weeks
Withdrawal from study
Number of participants and reasons for withdrawal
Time frame: 8 weeks
Adherence to study
Completion of supervised exercise sessions and application of the sensors, number of exercise sessions attended and number of days with sensors applied
Time frame: 8 weeks
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