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Exercise and Compression for Lymphedema (DREAM Trial)

N/A

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

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

Must have

Is agreeable to discontinuing other lymphedema treatments that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week RCT period of the study

Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

DREAM Trial Summary

This trial is investigating the benefit of combining resistance exercise with use of a compression sleeve or wrap on arm lymphedema.

Who is the study for?

This trial is for women with a history of breast cancer who have undergone surgery and have mild to moderate unilateral arm lymphedema for at least 3 months. They must use a compression sleeve daily and agree not to use other lymphedema treatments during the study. Excluded are those currently receiving cancer treatment, with limb infections, deep vein thrombosis, active metastatic disease, or conditions that could affect participation.Check my eligibility

What is being tested?

The study tests if resistance exercise combined with wearing a compression sleeve can benefit women with arm lymphedema after breast cancer surgery. Participants will follow a 'decongestive progressive resistance exercise' program while using either their usual compression sleeve or an adjustable wrap during workouts.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the compression garments and muscle soreness from the exercises. There might also be skin irritation under the garment or increased swelling if the garment doesn't fit properly.

DREAM Trial Eligibility Criteria

Inclusion Criteria

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

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I agree to stop any special lymphedema treatments for 12 weeks.

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

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I have noticeable swelling in one arm due to lymphedema, meeting the specified volume differences.

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I am a woman who has had breast cancer.

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I am in the maintenance phase for my lymphedema treatment.

DREAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Lymphedema Arm Volume

Secondary outcome measures

Change in Extracellular Fluid Volume

Change in Grip Strength

Change in Muscle Strength

+5 more

DREAM Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: DPRE + compression sleeve during exerciseExperimental Treatment3 Interventions

Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)

Group II: DPRE + AC garment during exerciseExperimental Treatment3 Interventions

Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).

Group III: Standard of CareActive Control2 Interventions

Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,172 Total Patients Enrolled

1 Trials studying Lymphedema

120 Patients Enrolled for Lymphedema

Media Library

Decongestive Progressive Resistance Exercise program Clinical Trial Eligibility Overview. Trial Name: NCT05022823 — N/A

Lymphedema Research Study Groups: Standard of Care, DPRE + compression sleeve during exercise, DPRE + AC garment during exercise

Lymphedema Clinical Trial 2023: Decongestive Progressive Resistance Exercise program Highlights & Side Effects. Trial Name: NCT05022823 — N/A

Decongestive Progressive Resistance Exercise program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022823 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for individuals to participate in this research?

"Affirmatively, the details on clinicaltrials.gov demonstrate that this experimental protocol is actively recruiting participants. It was initially posted to the website on May 27th 2022 and has been updated as recently as the same day. The study requires 40 individuals to be found at a single medical centre."

Answered by AI

How many participants are actively engaged in this clinical research endeavor?

"Yes, the information on clinicaltrials.gov verifies that this medical trial is actively enrolling individuals at this time. The initial posting of the study occurred on May 27th 2022 and has since been amended; 40 subjects are required from a single location for full enrollment."

Answered by AI