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Decongestive Progressive Resistance Exercise with Advanced Compression for Breast Cancer related Lymphedema Management
(DREAM): A Randomized Controlled Trial
The Cancer Rehabilitation Clinic at the University of Alberta is conducting a study on breast cancer related lymphedema. DREAM is a study to see whether combining compression with strength training will result in improved arm swelling in individuals with breast cancer.
What is the purpose of this study?
The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, individuals with breast cancer will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called “decongestive progressive resistance exercise” (DPRE). We will also evaluate the use of two different kinds of compression garments that can be worn on the arm during exercise. Some participants will wear their usual day-time compression sleeve during exercise and others will use an adjustable compression wrap during exercise.
We hope to see if this type of combined program of exercise and compression on the arm is helpful for individuals with lymphedema. We also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regular day-time compression sleeve.
What Treatments are provided in the study?
If you decide to participate then you will be "randomized" into one of the three groups described below. You will have an equal chance of being assigned to group 1, 2 or 3. Neither you, the study staff, nor the study investigator can choose what group you will be in.
Group 1 (Standard care group):
If you are randomized into this group, you will receive the usual care for lymphedema maintenance. You will be provided with a home program of therapeutic (decongestive) exercise, which will include active, unresisted motion of the involved limb. Exercises will follow a specific order that aims to stimulate lymphatic flow in your trunk and arm. You will perform the exercise once daily for about 10 minutes and you will be required to wear your compression sleeve for at least 12 hours per day, each day of the week for 12 weeks.
After 12 weeks, you will start a supervised DPRE program twice a week for 12 weeks and follow the program as outlined in Group 3 below.
Group 2 (DPRE group with compression sleeve):
If you are randomized into this group, you will participate in a supervised DPRE program twice a week for 12 weeks. If you are living in Edmonton, you will have the option to attend the group-based exercise sessions at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta (depending on COVID-19 restrictions), or attend group-based sessions virtually from your home. If you are living in Calgary, you will be offered the group-based exercise sessions virtually. You will be required to wear your daytime compression sleeve during the DPRE program and you will continue to wear your compression sleeve for at least 12 hours per day, each day of the week. Exercise sessions will take approximately 60-90 minutes. Each session will start with at least 5 minutes of stretching and deep breathing followed by the progressive resistance exercise program. Exercises will follow the specific order that aims to stimulate lymphatic flow in your trunk and arm.
After 12 weeks, you will continue the same program twice weekly for an additional 12 weeks independently at home or in a community-based fitness center, or you can join the virtual group-based exercise sessions.
Group 3 (DPRE group with Adjustable Compression Wrap):
If you are randomized to this group, you will be fitted for an adjustable compression wrap. You will be required to wear the adjustable compression wrap during the DPRE program and you will continue wearing your usual compression sleeve at least 12 hours per day, each day of the week. You will participate in a supervised group-based DPRE program twice a week for 12 weeks. If you are living in Edmonton, you will have the option to attend the exercise sessions at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta (depending on COVID-19 restrictions), or attend group-based sessions virtually from your home. If you are living in Calgary, you will be offered the group-based exercise sessions virtually. Exercise sessions will take approximately 60-90 minutes. Each session will start with at least 5 minutes of stretching and deep breathing followed by a progressive resistance exercise program. Exercises will follow the specific order that aims to stimulate lymphatic flow in your trunk and arm.
After 12 Weeks, you will continue the same program twice weekly for an additional 12 weeks independently at home or in a community-based fitness center, or you can join the virtual group-based sessions.
What will my participation involve?
The following established procedures will be done as part of this study.
Height and weight: we will measure your height and weight at the start of the study, and your weight at the follow-up sessions at 12 and 24 weeks. These measurements will take less than 1 minute. If you have a scale at home, we will also ask you to take your weight.
Arm volume measurements – we will measure your arm using a Perometer. The perometer is an opto-electric volumeter which provides information on the size of your arms. This measurement will help us to identify the total volume difference between your arms with and without lymphedema and to detect any changes during and following the treatment program. The Perometer measurements take 2-5 minutes.
We will also teach you how to take measurements of your arm using a tape measure. You will do these measurements at baseline, 12-week, and 24-week testing sessions. This measurement takes 5-10 minutes to complete.
Muscle strength – we will use the one-repetition maximum strength test of your arms pushing (with bench press) and pulling (seated row) and the pushing strength of your legs (with the leg press). Your hand grip strength will be assessed using the dynamometer. These tests will help us to identify your muscle strength level before the study and your progression during (12 weeks) and after the study (24 weeks). This testing takes 10-15 minutes to complete.
Range of motion of the shoulder – we will measure the range of your shoulder movement with a plastic goniometer for movements overhead, out to the side and when rotating the arm. These measurements will help us to identify any limitations in your shoulder movement. This testing takes 5-10 minutes to complete.
Arm fluid – we will measure your arm fluid using Bioimpedance analysis (BIA). BIA is a technology that measures the resistance to a very small electrical signal applied to the arm. Bioimpedance is able to detect even small differences in fluid levels between your arms, which may go unnoticed with the other measurement methods. Electrodes will be placed on the back of your hands, your wrists and on the top of one foot. A small harmless electrical signal will be passed through the electrodes in your arms. You will not be able to feel the signal passing through your arms. Bioimpedance is painless and and takes 2-3 minutes to complete. Although there is no evidence of harm from use of BIA, it is not recommended if you have a pacemaker, metal implants or if you may be pregnant. In this situation, the BIA test will not be done; however, you will still be able to participate in the study.
Muscle mass, fat, and fluid measurements – your arm will be measured using Magnetic Resonance Imaging (MRI). The MRI will provide information on how much muscle, fat, and fluid is in each of your arms. This measurement will help us to see differences between your arms with and without lymphedema, and to detect any changes following the treatment program. The MRI is safe and does not use any type of radiation. The MRI measurements take 20-30 minutes. The MRI measurement will be done at baseline, 12-week and 24-week testing sessions. Before MRI measurement, you will be asked to fill out a short screening questionnaire to assess your eligibility. If you agree to this test, you will sign a separate consent form.
Questionnaires: You will be provided with questionnaires (electronic or paper copy) before starting this study, and at 12 weeks and 24 weeks follow-up. The purpose of the questionnaires is to understand how the treatment impacts your function and quality of life.
Lymphedema-related Quality of Life – We will assess your quality of life using this specific lymphedema questionnaire. It contains 29 questions related to functional impairments, activity limitations, and participation restrictions due to arm swelling. This questionnaire will take about 7 minutes to complete.
Health-related Quality of Life – We will assess your general health- related quality of life using the Rand Short Form-36 (SF-36). It involves 36 questions about your mental health, physical health, social health, function, pain, vitality/energy, and health perceptions. It is easy to use and takes about 8 minutes to complete.
Body Image – We will assess your body image using the Body Image and Relationship Scale (BIRS) questionnaire. It contains 32 questions about your attitudes towards your appearance, health, physical strength, sexuality, relationships, and social functioning after breast cancer treatment. This questionnaire takes 2-3 minutes to complete.
Physical activity level – We will assess your physical activity level using the Godin leisure-time exercise questionnaire. The questionnaire asks you about the average intensity, duration, and frequency of your physical activity. This questionnaire will take about 2-3 minutes to complete.
Diaries – You will be asked to keep track of your exercise and compression garment use through diary or program adherence sheet. You will be required to record the exercise sessions performed each day (including sets, repetitions and resistance weight). You will also record the compression garment use during exercise, and the number of hours per day you used the compression sleeve. You will be asked to return the diary for each follow-up appointment at 12, and 24 weeks to the cancer rehabilitation clinic in Corbett Hall, University of Alberta or submit an electronic copy to the researchers.
Am I eligible for the study?
You are eligible for the study if you:
Are a female with breast cancer;
Have finished all of your cancer treatment;
Have mild to moderate swelling in your arm that has occurred as a result of your breast cancer treatment;
Are in the maintenance phase of lymphedema treatment;
Have a newly fitted compression sleeve (not older than 1 month).
For more information about the study, please contact:
The Study Coordinator
Mona Al Onazi
phone number: 780-492-6007
The Study Investigator:
Dr. Margie McNeely
phone number: 780-492-6007
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