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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653819
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Merete Celano Wittenkamp, 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.


Condition or disease Intervention/treatment Phase
Lymphedema of Leg Cancer of Cervix Cancer, Ovarian Cancer, Endometrial Cancer of the Prostate Malignant Melanoma Other: First exercise session + compression Other: First exercise session - compression Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018


Arm Intervention/treatment
HIIT + compression
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.
Other: First exercise session + compression
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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653819


Locations
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Denmark
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev and Gentofte Hospital
University of Copenhagen
Investigators
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Principal Investigator: Merete C Wittenkamp, PT Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,
Study Chair: 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

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Responsible Party: Merete Celano Wittenkamp, Pricipal Investigator, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03653819    
Other Study ID Numbers: Lympha feasibility
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merete Celano Wittenkamp, Herlev and Gentofte Hospital:
Compression Stockings
Feasibility Study
Physical Activity
High Intensity Interval Training
Cross over trial
Additional relevant MeSH terms:
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Melanoma
Prostatic Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Lymphedema
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Lymphatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders