Exercise and Compression for Lymphedema
(DREAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a combination of exercise and compression garments can reduce arm swelling in women with lymphedema after breast cancer surgery. Participants will try different compression methods alongside exercises to determine which is more effective. Women who have undergone breast cancer surgery and experience mild to moderate arm swelling lasting at least three months may be suitable candidates. The goal is to discover if these combined treatments can positively impact lymphedema management. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance lymphedema management for future patients.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must stop other lymphedema treatments like manual lymph drainage and intermittent pneumatic compression during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both types of compression used in the trial are safe and effective for managing lymphedema, which is swelling caused by a build-up of lymph fluid. Studies have found that the compression sleeve helps reduce swelling in the limbs and does not worsen lymphedema symptoms during exercise. Most people find these garments comfortable, especially if they have swelling in their legs, though some find it harder to use them on their arms.
For those using the adjustable compression wrap, research indicates it effectively controls swelling and works as well as other methods like multilayer bandages. Reports confirm that these wraps are safe and do not cause any major unwanted effects.
Overall, both treatments are considered safe and effective for managing lymphedema in breast cancer survivors, with good adherence from participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores new ways to manage lymphedema through exercise and compression techniques. Unlike current standard care, which typically involves non-resistive exercises and compression sleeves, this trial examines the effects of combining decongestive progressive resistance exercises with either a compression garment or an adjustable compression wrap. The unique aspect here is the integration of resistance exercises, which could potentially enhance lymphatic drainage and improve limb function more effectively. By investigating these new combinations, researchers hope to discover more efficient methods to alleviate symptoms and improve quality of life for those with lymphedema.
What evidence suggests that this trial's treatments could be effective for lymphedema?
Research shows that wearing a compression garment during exercise can help reduce arm swelling in women who have undergone breast cancer surgery. In this trial, one group will use a compression garment during exercise, while another group will use adjustable compression wraps. Studies suggest that using these garments in the first few months after surgery may lower the risk of developing lymphedema, a condition that causes swelling. Exercise itself helps move fluid in the body, which can also reduce swelling. For those using adjustable compression wraps, research indicates they are effective and comfortable, with most users willing to continue using them. Both methods aim to improve quality of life by reducing swelling and increasing movement.678910
Who Is on the Research Team?
Margaret L McNeely, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for women who have had breast cancer surgery and are dealing with arm swelling (lymphedema) on the same side. They must be using a compression sleeve, not be receiving other lymphedema treatments during the study, and have chronic lymphedema for at least 3 months. Women with severe obesity, heart issues, infections in the limb, or undergoing cancer therapies cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 12-week decongestive progressive resistance exercise program with advanced compression
Extended Treatment
Participants continue the exercise program for an additional 12 weeks in a community-based fitness center or at home
Follow-up
Participants are monitored for changes in arm lymphedema volume, function, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Exercise and Adjustable Compression Wrap
- Exercise and Compression Garment
- Standard Care
Trial Overview
The study tests if a 12-week exercise program combined with wearing advanced compression garments can reduce swelling from lymphedema in breast cancer survivors. Participants will either continue standard care or use an adjustable wrap or garment while exercising to see which method is more effective.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home.
Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home.
Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise.
Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:
- Smoking cessation
- Smoking cessation
- Smoking cessation
- Smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Cross Cancer Institute
Collaborator
Published Research Related to This Trial
Citations
A randomized, controlled noninferiority study of adjustable ...
Adjustable compression wraps showed fewer side effects, and 83.3% of participants indicated they would continue using them. No adverse events were attributed to ...
Adjustable Compression Wraps (ACW) in Lymphedema
The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap ( ...
Prospective, randomized, controlled trial comparing the ...
This prospective, randomized, controlled comparative study assessed the effectiveness of an ACW in the treatment of leg lymphedema, compared with the ...
Decongestive progressive resistance exercise with an ...
... adjustable compression wrap during exercise. The primary outcome is the percentage reduction in arm lymphoedema volume. Secondary outcomes ...
5.
lymphoedemaeducation.com.au
lymphoedemaeducation.com.au/wp-content/uploads/2017/06/3b.-A-review-of-the-evidence-for-adjustable-compression-wrap-devices.pdfA review of the evidence for adjustable compression wrap ...
Compression therapy is a key component in the effective management of people with lower limb problems associated with venous, lymphatic and fat disorders ...
Efficacy, safety of and adherence to adjustable ...
Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.
A randomized, controlled noninferiority study of adjustable ...
Adjustable compression wraps were noninferior to inelastic multilayer bandages with a mean difference in volume reduction of 9.45 mL (95% confidence interval − ...
A randomized controlled trial - Jéssica Malena Pedro da ...
The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, ...
Decongestive progressive resistance exercise with an ...
The primary outcome is the percentage reduction in arm lymphoedema volume. Secondary outcomes include bioimpedance analysis, muscular strength, shoulder range ...
NCT05022823 | Exercise and Compression for Lymphedema
The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.