Clinical trial NCT03653819: High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility rate
timeFrame: After 3 months
measure: Completion rate
timeFrame: After 3 months
Secondary outcomes:
measure: Participant satisfaction
timeFrame: Week 2
measure: Change in pain related to lymphedema
timeFrame: Hour 0 and 1 post each exercise sessions
measure: Change in tension related to lymphedema
timeFrame: Hour 0 and 1 post each exercise sessions
measure: Change in heaviness related to lymphedema
timeFrame: Hour 0 and 1 post each exercise sessions
measure: Change in volume of lower limbs
timeFrame: Hour 0 and hour 1 post each exercise sessions
measure: Change in extracellular fluid in the lower limbs
timeFrame: Hour 0 and hour 1 post each exercise session
measure: Change in weight of the lower limbs
timeFrame: Hour 0 and hour 1 post each exercise session
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Study officials:
affiliation: Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,
name: Merete C Wittenkamp, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark.
name: Carsten B Juhl, PT MPH PhD
role: STUDY_CHAIR
affiliation: Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
name: Anders Vinther, PT MSc PhD
role: STUDY_CHAIR
References: