Exercise and Compression for Lymphedema
DREAM
Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2024
CompletedJune 27, 2025
June 1, 2025
1.6 years
August 16, 2021
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lymphedema Arm Volume
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
Up to 24 weeks
Secondary Outcomes (8)
Change in Extracellular Fluid Volume
Up to 24 weeks
Change in Muscle Strength
Up to 24 weeks
Change in Grip Strength
Up to 24 weeks
Change in Shoulder Range of Motion
Up to 24 weeks
Health-Related Quality of Life (Lymph-ICF)
Up to 24 weeks
- +3 more secondary outcomes
Study Arms (3)
Standard of Care
ACTIVE COMPARATORGroup A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)
DPRE + compression sleeve during exercise
EXPERIMENTALGroup B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)
DPRE + AC garment during exercise
EXPERIMENTALGroup C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).
Interventions
Participants wear their daytime compression sleeve during the DPRE program.
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.
Compression sleeve worn for at least 12 hours per day, seven days a week.
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.
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.
Eligibility Criteria
You may qualify if:
- Is a female with a history of breast cancer;
- Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
- 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;
- Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
- Is in the lymphedema maintenance phase of conservative treatment;
- 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);
- 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.
- Is able to read and understand English.
You may not qualify if:
- Are undergoing or are scheduled to receive chemotherapy or radiotherapy
- Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease;
- 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;
- Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Related Publications (1)
Al Onazi MM, Campbell KL, Thompson RB, Ghosh S, Mackey JR, Muir A, McNeely ML. Decongestive progressive resistance exercise with an adjustable compression wrap for breast cancer-related lymphoedema (DREAM): protocol for a randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e053165. doi: 10.1136/bmjopen-2021-053165.
PMID: 35379618DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2021
First Posted
August 26, 2021
Study Start
June 29, 2022
Primary Completion
February 8, 2024
Study Completion
February 8, 2024
Last Updated
June 27, 2025
Record last verified: 2025-06