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Completed

NCT Number: NCT03653819

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

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.

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Key information

Conditions

Lymphedema of Leg Adnexal Diseases Behavior Cancer of Cervix Cancer of the Prostate Cancer, Endometrial Cancer, Ovarian Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Malignant Melanoma Melanoma Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility rate

    Time frame: After 3 months

    Number of invited eligible participants enrolled in the study

  2. Completion rate

    Time frame: After 3 months

    Number of enrolled participants completing both interventions

Secondary outcomes

  1. Participant satisfaction

    Time frame: 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.

  2. Change in pain related to lymphedema

    Time frame: 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.

  3. Change in tension related to lymphedema

    Time frame: 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.

  4. Change in heaviness related to lymphedema

    Time frame: 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.

  5. Change in volume of lower limbs

    Time frame: 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

  6. Change in extracellular fluid in the lower limbs

    Time frame: Hour 0 and hour 1 post each exercise session

    Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.

  7. Change in weight of the lower limbs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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