Lymphedema of LegNCT03653819
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
A study testing First exercise session + compression and First exercise session - compression in people with Lymphedema of Leg and Cancer of Cervix, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Leg, Cancer of Cervix, Cancer, Ovarian
- What is being tested?
- First exercise session + compression and First exercise session - compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Sep 2018to 13 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Herlev, 2730
About this study
Official title: High Intensity Interval Training (HIIT) on Stationary Bike With and Without Compression Stockings for Patients With Cancer-related Lymphedema in the Lower Limbs - a Feasibility Study
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.
Read the detailed description
Lymphedema is a condition afflicting cancer patients who undergo surgery with removal of lymph nodes, chemotherapy and radiation. Lymphedema is a consequence of impaired lymphatic drainage in the interstitium, which causes edema and inflammation in the subcutaneous tissue. The symptoms are swelling, puffiness, tightness, heaviness and pain in the affected area.
Lymphedema can be reduced by complete decongestive therapy, which consists of skin care, manual lymphatic drainage, compression bandaging and exercise. At the end of treatment, patients are provided with custommade compression garments to be worn during daytime in order to maintain the reduction in the edema.
Lymphedema has a negative impact on activities of daily living and health-related quality of life. Patients with lymphedema should be encouraged to engage in physical activity despite their condition in order to prevent relapse of cancer and development of other diseases. Likewise physical activity helps to maintain a healthy weight, which is important as obesity has a negative impact on lymphedema. The lymphatic system is also stimulated by physical activity and exercise and can reduce the symptoms from the lymphedema.
Several studies have been published on the safety and benefits of exercise for women with breastcancer related lymphedema. However, only a few studies have investigated the feasibility of exercise to patients with lymphedema in the lower limbs. Also the role of compression garments during exercise have not been throughly explored.
- Conditions
- Lymphedema of Leg, Cancer of Cervix, Cancer, Ovarian, Cancer, Endometrial, Cancer of the Prostate, Malignant Melanoma
- Being tested
- First exercise session + compression, First exercise session - compression
- Keywords
- Compression Stockings, Feasibility Study, Physical Activity, High Intensity Interval Training, Cross over trial
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Prostatic Neoplasms, Melanoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First exercise session + compressionOther
The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.
First exercise session - compressionOther
The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| HIIT + compression | Other | 2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without. Receives: Other: First exercise session + compression |
| HIIT - compression | Other | 2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with Receives: Other: First exercise session - compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility rate
Number of invited eligible participants enrolled in the study
Measured: After 3 months
Completion rate
Number of enrolled participants completing both interventions
Measured: After 3 months
Secondary outcomes (7)
Participant satisfaction
At the end of the study participation, data describing participant satisfaction will be collected to answers questions on acceptability. All participants will be given a questionnaire and will be asked to rank various aspects of the intervention including exercising without compression garments "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very satisfied". Feasibility will be defined as >75% of participants reporting they are "very" or "somewhat satisfied" with the intervention.
Measured: Week 2
Change in pain related to lymphedema
Participant-reported pain measured on a numeric range scale 0-10, "0" indicating no pain and "10" as worst imaginable pain. Measurements will be made immediately before and after each exercise session.
Measured: Hour 0 and 1 post each exercise sessions
Change in tension related to lymphedema
Participant-reported tension measured on a numeric range scale 0-10, "0" indicating no tension and "10" worst imaginable tension. Measurements will be made immediately before and after each exercise session.
Measured: Hour 0 and 1 post each exercise sessions
Change in heaviness related to lymphedema
Participant-reported heaviness measured on a numeric range scale 0-10, "0" indicating no heaviness and "10" worst imaginable heaviness. Measurements will be made immediately before and after each exercise session.
Measured: Hour 0 and 1 post each exercise sessions
Change in volume of lower limbs
Tape Measurements(cm) at 8 cm intervals, converted to volume (ml) by formula of truncated cone. Measurements will be made immediately before and after each exercise session
Measured: Hour 0 and hour 1 post each exercise sessions
Change in extracellular fluid in the lower limbs
Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.
Measured: Hour 0 and hour 1 post each exercise session
Change in weight of the lower limbs
Dual Energy Xray Absorptiometry, a full body scan is performed. Afterwards regions of interest is marked and weight of each lower limb calculated. Measurements will be made immediately before and after each exercise session.
Measured: Hour 0 and hour 1 post each exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start6 Sep 2018
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Merete Celano Wittenkamp, Herlev and Gentofte Hospital
- Investigators
- Merete C Wittenkamp, PT, Principal investigator, Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,Carsten B Juhl, PT MPH PhD, Study chair, Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark.Anders Vinther, PT MSc PhD, Study chair, Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653819
- Sponsor's protocol ID
- Lympha feasibility
- Status last verified
- Nov 2018
- First submitted
- 23 Aug 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wittenkamp MC, Juhl CB, Zerahn B, Vinther A. Exercise and cancer-related lymphedema in the lower limbs-a randomized cross-over trial on high-intensity interval training (HIIT) with and without compression garments. Support Care Cancer. 2025 Apr 16;33(5):391. doi: 10.1007/s00520-025-09458-x.
PubMed 40240614
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training (HIIT) on Stationary Bike With and Without Compression Stockings for Patients With Cancer-related Lymphedema in the Lower Limbs - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03653819
- Acronym / sponsor ID
- Lympha feasibility
- Conditions
- Lymphedema of Leg, Cancer of Cervix, Cancer, Ovarian, Cancer, Endometrial, Cancer of the Prostate, Malignant Melanoma
- Keywords
- Compression Stockings, Feasibility Study, Physical Activity, High Intensity Interval Training, Cross over trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lymphedema is a condition afflicting cancer patients who undergo surgery with removal of lymph nodes, chemotherapy and radiation. Lymphedema is a consequence of impaired lymphatic drainage in the interstitium, which causes edema and inflammation in the subcutaneous tissue. The symptoms are swelling, puffiness, tightness, heaviness and pain in the affected area.
Lymphedema can be reduced by complete decongestive therapy, which consists of skin care, manual lymphatic drainage, compression bandaging and exercise. At the end of treatment, patients are provided with custommade compression garments to be worn during daytime in order to maintain the reduction in the edema.
Lymphedema has a negative impact on activities of daily living and health-related quality of life. Patients with lymphedema should be encouraged to engage in physical activity despite their condition in order to prevent relapse of cancer and development of other diseases. Likewise physical activity helps to maintain a healthy weight, which is important as obesity has a negative impact on lymphedema. The lymphatic system is also stimulated by physical activity and exercise and can reduce the symptoms from the lymphedema.
Several studies have been published on the safety and benefits of exercise for women with breastcancer related lymphedema. However, only a few studies have investigated the feasibility of exercise to patients with lymphedema in the lower limbs. Also the role of compression garments during exercise have not been throughly explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
| Arm | Type | Receives |
|---|---|---|
| HIIT + compression | Other | Other: First exercise session + compression2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without. |
| HIIT - compression | Other | Other: First exercise session - compression2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First exercise session + compressionThe Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs. | Other | HIIT + compression |
| First exercise session - compressionThe Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs. | Other | HIIT - compression |
Primary outcome
Feasibility rate
Time frame: After 3 months
Number of invited eligible participants enrolled in the study
Completion rate
Time frame: After 3 months
Number of enrolled participants completing both interventions
7 secondary outcomes
Participant satisfaction
Time frame: Week 2
Change in pain related to lymphedema
Time frame: Hour 0 and 1 post each exercise sessions
Change in tension related to lymphedema
Time frame: Hour 0 and 1 post each exercise sessions
Change in heaviness related to lymphedema
Time frame: Hour 0 and 1 post each exercise sessions
Change in volume of lower limbs
Time frame: Hour 0 and hour 1 post each exercise sessions
Change in extracellular fluid in the lower limbs
Time frame: Hour 0 and hour 1 post each exercise session
Change in weight of the lower limbs
Time frame: Hour 0 and hour 1 post each exercise session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Derived from this study: PubMed 40240614Wittenkamp MC, Juhl CB, Zerahn B, Vinther A. Exercise and cancer-related lymphedema in the lower limbs-a randomized cross-over trial on high-intensity interval training (HIIT) with and without compression garments. Support Care Cancer. 2025 Apr 16;33(5):391. doi: 10.1007/s00520-025-09458-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete C Wittenkamp, PT principal investigator
Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,
Carsten B Juhl, PT MPH PhD study chair
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark.
Anders Vinther, PT MSc PhD study chair
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First exercise session + compression and First exercise session - compression in people with Lymphedema of Leg and Cancer of Cervix, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility rate (time frame: After 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.