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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Week 1-2 no exercise, week 3 washout, week 4-5 exercise without compression, week 6 washout, week 7-8 exercise with compression |
|
| Group B | Experimental | Week 1-2 exercise without compression, week 3 washout, week 4-5 exercise with compression, week 6 washout, week 7-8 no exercise |
|
| Group C | Experimental | Week 1-2 exercise with compression, week 3 washout, weekend 4-5 no exercise, week 6 washout, week 7-8 exercise without compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance exercise | Other | Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower leg circumference | circumferential sensor CIMON, measured in Picoferens (pF) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Limb volume | perometry, volume (mL) | 14 days |
| Lower Limb volume | circumferential measurements, 8 cm interval, converted to volume (mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merete C Wittenkamp, PhD student | Contact | 93911784 | merete.celano.wittenkamp@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Carsten B Juhl, Professor | Herlev Gentofte Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy | Recruiting | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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Statistician will be blinded for group allocation
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| 14 days |
| Edema of the foot and ankle | Figure of eight with tape measure, (cm) | 14 days |
| Extracellular fluid of the lower limb | Bioimpedance Spectroscophy, (L-dex) | 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/%) | 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) | 14 days |
| Self reported lymphedema symptoms | Pain, tension, heaviness, tinkling, numeric ranking scale 0-10 | 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 | 14 days |
| Adverse events | E.g. skin irritation, cellulitis, severe muscle injury, number of events | 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 | 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 | 8 weeks |
| Withdrawal from study | Number of participants and reasons for withdrawal | 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 | 8 weeks |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |