The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resistance exercise.
- Who it may be relevant to
- Registry conditions: Lymphedema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema - With and With-out Compression - a Randomized Controlled Trial (the LymphEx Study)
Overview
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
- Other Resistance exercise
Supervised resistance exercise targeted at the larger muscle groups in the lower limbs, 5 exercises, 3 sets of 10RM
Primary outcome measures
- Lower leg circumference [Time frame: 14 days]
Secondary outcome measures (12)
- Lower Limb volume [Time frame: 14 days]
- Lower Limb volume [Time frame: 14 days]
- Edema of the foot and ankle [Time frame: 14 days]
- Extracellular fluid of the lower limb [Time frame: 14 days]
- Body composition [Time frame: 14 days]
- Segmental body composition of the lower limbs [Time frame: 14 days]
- Self reported lymphedema symptoms [Time frame: 14 days]
- Physical activity [Time frame: 14 days]
- Adverse events [Time frame: 14 days]
- Adherence to compression [Time frame: 14 days]
- Adherence to study [Time frame: 8 weeks]
- Withdrawal from study [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Herlev and Gentofte Hospital, Department of Physiotherapy and Occupational Therapy — Herlev
Identifiers
NCT: NCT07558317 · LymphEx