Exercise and Compression for Lymphedema (DREAM)

June 24, 2025 updated by: AHS Cancer Control Alberta

Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial

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, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Is a female with a history of breast cancer;
  2. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
  3. Has visible and palpable unilateral mild to moderate BCRL of at least 200 ml inter-limb volume difference (full limb) or regional lymphedema: defined as a minimal volume difference of 100 ml or 5% in a segment of the arm (e.g. hand and forearm region, elbow and upper arm) after correcting for arm dominance;
  4. Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
  5. Is in the lymphedema maintenance phase of conservative treatment;
  6. Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of pressure);
  7. 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.
  8. Is able to read and understand English.

Exclusion Criteria:

  1. Are undergoing or are scheduled to receive chemotherapy or radiotherapy
  2. Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease;
  3. Has any neurological or cognitive deficit, is pregnant, uses a pacemaker, or has other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
  4. Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)
Device: Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
Behavioral: Home exercise program
Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.
Experimental: DPRE + compression sleeve during exercise
Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)
Device: Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
Device: Compression sleeve, worn during exercise
Participants wear their daytime compression sleeve during the DPRE program.
Behavioral: Decongestive Progressive Resistance Exercise program

Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.

After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.

Other Names:
  • DPRE
Experimental: DPRE + AC garment during exercise
Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).
Device: Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
Behavioral: Decongestive Progressive Resistance Exercise program

Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.

After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.

Other Names:
  • DPRE
Device: Adjustable Compression (AC) garment, worn during exercise
Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lymphedema Arm Volume
Time Frame: Up to 24 weeks
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Extracellular Fluid Volume
Time Frame: Up to 24 weeks
Bioimpedance analysis (BIA) is specially designed to estimate extracellular fluid volume in the limb. BIA measures the impedance ratio of the affected and unaffected limb and the resulting calculated index provides an estimate of extracellular fluid volume.
Up to 24 weeks
Change in Muscle Strength
Time Frame: Up to 24 weeks
Muscle strength will be assessed with the one-repetition maximum (1-RM) method for bench press, leg press, and seated row. The 1-RM is the highest weight that can be lifted once using proper form, a smooth motion and without pain or other symptoms.
Up to 24 weeks
Change in Grip Strength
Time Frame: Up to 24 weeks
The Jamar hydraulic hand dynamometer will be used to measure grip strength.
Up to 24 weeks
Change in Shoulder Range of Motion
Time Frame: Up to 24 weeks
Shoulder range of motion (ROM) will be measured using plastic goniometer and each arm will be measured separately for flexion, abduction, internal, external rotation, and horizontal abduction.
Up to 24 weeks
Health-Related Quality of Life (Lymph-ICF)
Time Frame: Up to 24 weeks
The Lymphedema Functioning, Disability, and Health (Lymph-ICF) questionnaire consists of 29 questions related to functional impairments, activity limitations, and participation restrictions in patients with upper limb lymphedema.The total score of the Lymph-ICF on the five areas ranges from 0 to 100, with a score of 0 meaning no impact and higher scores indicative of worse function or negative impact.
Up to 24 weeks
Health-Related Quality of Life (SF-36)
Time Frame: Up to 24 weeks
The Rand Short Form-36 Version 2 (SF-36) questionnaire is comprised of 36 questions that aim to evaluate the following eight models of HRQOL: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality/energy, social functioning, role limitations due to emotional problems, and general mental health.
Up to 24 weeks
Physical Activity Level
Time Frame: Up to 24 weeks
The Godin leisure-time exercise questionnaire (GLTEQ) will be used to assess the physical activity level. The Godin questionnaire is a self reported measure of the average duration and frequency of strenuous (heart beats rapidly), moderate (not exhausting), and mild activities (minimal effort), resistance training, and flexibility training exercise.
Up to 24 weeks
Exercise and Compression Adherence
Time Frame: Up to 24 weeks
Participants will be asked to record their adherence to their assigned exercise and compression intervention program using a daily diary.The adherence diary will collect details on exercise sessions performed each day, including sets, repetitions, and resistance weight, as well as use of the assigned compression sleeve (i.e. use of the garment during exercises and number of hours per day and days per week the compression sleeve is worn).
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-0016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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