High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower … (NCT03653819) | Clinical Trial Compass
CompletedNot Applicable
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
Denmark20 participantsStarted 2018-09-06
Plain-language summary
The aim of the study is to explore the feasibility and safety of High Intensity Interval Training on a stationary bike for patients with lymphedema in the lower limbs and the role of compression garments during exercise.
The design of the study is a cross-over randomized clinical trial. Participants will be randomized into two groups. Both will perform two separate exercise sessions.Group A will perform the first exercise with compression garment and the second session without compression garment, with wash-out period of 1 week between sessions. Group B will perform the exercise sessions in the opposite order.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* unilateral or bilateral lymphedema in the lower limbs
* secondary lymphedema
* wears custommade compression stockings during daytime
* lymphedema in stage 1, 2A or 2B (Classification from the International Society of Lymphology)
* legally competent persons with ability to read and understand Danish.
Exclusion Criteria:
* inability to perform the intervention, as assessed by the person performing inclusion.
* lymphedema in stage 0 or 3 (Classification from the International Society of Lymphology)
* ongoing complete decongestive lymphedema therapy
* untreated erysipelas
* ongoing oncologic treatment: chemotherapy, radiation, immune therapy,
* known metastatic cancer
* comorbidities e.g. deep venenous thrombosis, serious heart disease, renal insufficiency
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.