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

November 14, 2018 updated by: Merete Celano Wittenkamp, Herlev and Gentofte Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility rate
Time Frame: After 3 months
Number of invited eligible participants enrolled in the study
After 3 months
Completion rate
Time Frame: After 3 months
Number of enrolled participants completing both interventions
After 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 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.
Hour 0 and 1 post each exercise sessions
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.
Hour 0 and 1 post each exercise sessions
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.
Hour 0 and 1 post each exercise sessions
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
Hour 0 and hour 1 post each exercise sessions
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.
Hour 0 and hour 1 post each exercise session
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.
Hour 0 and hour 1 post each exercise session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Collaborators

University of Copenhagen

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lympha feasibility

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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