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High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs

H

Herlev and Gentofte Hospital

Status

Completed

Conditions

Malignant Melanoma
Cancer, Ovarian
Cancer of Cervix
Cancer, Endometrial
Lymphedema of Leg
Cancer of the Prostate

Treatments

Other: First exercise session - compression
Other: First exercise session + compression

Study type

Interventional

Funder types

Other

Identifiers

NCT03653819
Lympha feasibility

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

HIIT + compression
Other group
Description:
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.
Treatment:
Other: First exercise session + compression
HIIT - compression
Other group
Description:
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with
Treatment:
Other: First exercise session - compression

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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