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

Not Applicable

Completed

• Conditions: Lymphedema of Leg; Cancer of the Prostate; Cancer of Cervix; Cancer, Ovarian; Cancer, Endometrial; Malignant Melanoma
• Interventions: Other: First exercise session - compression; Other: First exercise session + compression

• Registration Number: NCT03653819
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-09-06
• Status Verified: 2018-11
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility rate	After 3 months	Number of invited eligible participants enrolled in the study
Completion rate	After 3 months	Number of enrolled participants completing both interventions

Secondary Outcome Measures

Name	Time	Method
Change in tension related to lymphedema	Hour 0 and 1 post each exercise sessions	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.
Change in weight of the lower limbs	Hour 0 and hour 1 post each exercise session	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.
Change in pain related to lymphedema	Hour 0 and 1 post each exercise sessions	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.
Change in volume of lower limbs	Hour 0 and hour 1 post each exercise sessions	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
Participant satisfaction	Week 2	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.
Change in heaviness related to lymphedema	Hour 0 and 1 post each exercise sessions	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.
Change in extracellular fluid in the lower limbs	Hour 0 and hour 1 post each exercise session	Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.

Trial Locations

Locations (1)

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark