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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT + compression | Other | 2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without. |
|
| HIIT - compression | Other | 2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First exercise session + compression | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility rate | Number of invited eligible participants enrolled in the study | After 3 months |
| Completion rate | Number of enrolled participants completing both interventions | After 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete C Wittenkamp, PT | Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital, | Principal Investigator |
| Carsten B Juhl, PT MPH PhD | Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark. | Study Chair |
| Anders Vinther, PT MSc PhD | Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40240614 | Derived | 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. |
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All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
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|
| First exercise session - compression | Other | 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. |
|
| 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. | 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. | 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. | 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 | 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. | 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. | Hour 0 and hour 1 post each exercise session |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008545 | Melanoma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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