High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
Primary Purpose
Lymphedema of Leg, Cancer of Cervix, Cancer, Ovarian
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
First exercise session + compression
First exercise session - compression
Sponsored by
About this trial
This is an interventional supportive care trial for Lymphedema of Leg focused on measuring Compression Stockings, Feasibility Study, Physical Activity, High Intensity Interval Training, Cross over trial
Eligibility 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
Sites / Locations
- Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HIIT + compression
HIIT - compression
Arm Description
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with
Outcomes
Primary Outcome Measures
Feasibility rate
Number of invited eligible participants enrolled in the study
Completion rate
Number of enrolled participants completing both interventions
Secondary Outcome Measures
Participant satisfaction
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 pain related to lymphedema
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 tension related to lymphedema
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 heaviness related to lymphedema
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 volume of lower limbs
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
Change in extracellular fluid in the lower limbs
Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.
Change in weight of the lower limbs
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.
Full Information
NCT ID
NCT03653819
First Posted
August 23, 2018
Last Updated
November 14, 2018
Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03653819
Brief Title
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Leg, Cancer of Cervix, Cancer, Ovarian, Cancer, Endometrial, Cancer of the Prostate, Malignant Melanoma
Keywords
Compression Stockings, Feasibility Study, Physical Activity, High Intensity Interval Training, Cross over trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIIT + compression
Arm Type
Other
Arm Description
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.
Arm Title
HIIT - compression
Arm Type
Other
Arm Description
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with
Intervention Type
Other
Intervention Name(s)
First exercise session + compression
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
First exercise session - compression
Intervention Description
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 Measure Information:
Title
Feasibility rate
Description
Number of invited eligible participants enrolled in the study
Time Frame
After 3 months
Title
Completion rate
Description
Number of enrolled participants completing both interventions
Time Frame
After 3 months
Secondary Outcome Measure Information:
Title
Participant satisfaction
Description
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.
Time Frame
Week 2
Title
Change in pain related to lymphedema
Description
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.
Time Frame
Hour 0 and 1 post each exercise sessions
Title
Change in tension related to lymphedema
Description
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.
Time Frame
Hour 0 and 1 post each exercise sessions
Title
Change in heaviness related to lymphedema
Description
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.
Time Frame
Hour 0 and 1 post each exercise sessions
Title
Change in volume of lower limbs
Description
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
Time Frame
Hour 0 and hour 1 post each exercise sessions
Title
Change in extracellular fluid in the lower limbs
Description
Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.
Time Frame
Hour 0 and hour 1 post each exercise session
Title
Change in weight of the lower limbs
Description
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.
Time Frame
Hour 0 and hour 1 post each exercise session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete C Wittenkamp, PT
Organizational Affiliation
Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carsten B Juhl, PT MPH PhD
Organizational Affiliation
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Vinther, PT MSc PhD
Organizational Affiliation
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
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