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Exercise and Compression for Lymphedema (DREAM Trial)

N/A

Waitlist Available

Led By Margaret L McNeely, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has unilateral mild to moderate lymphedema meeting specific volume criteria

Is agreeable to discontinuing other lymphedema treatments during the supervised intervention period of the study

Must not have

Are undergoing or scheduled for chemotherapy, radiotherapy, or biological therapy

Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change baseline to 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trialwill look at whether exercise & advanced compression can help reduce breast cancer-related lymphedema in 24 Edmonton survivors. #breastcancer #lymphedema

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing compression garments during exercise and possible skin irritation. The intensity of exercise could also cause general fatigue or muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have swelling in one arm or leg that is not too severe.

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I agree to stop other lymphedema treatments during the study.

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I have had surgery to remove lymph nodes due to my cancer.

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I wear a compression sleeve for at least 12 hours daily.

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I am a woman who has had breast cancer.

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I have had chronic swelling for at least 3 months.

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I am currently managing my lymphedema with ongoing treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing or scheduled for cancer treatment.

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I have an infection in my limb, deep vein thrombosis, cellulitis, or active cancer spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arm Lymphedema Volume

Secondary study objectives

Bioimpedance Analysis

Body Image

Body composition

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Exercise and Compression GarmentExperimental Treatment1 Intervention

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.

Group II: Exercise and Adjustable Compression WrapExperimental Treatment1 Intervention

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.

Group III: Standard CareActive Control1 Intervention

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.

0 / 9Eligibility criteria met