Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-06-29
2024-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Standard of Care
Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)
Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
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.
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)
Compression sleeve, worn during exercise
Participants wear their daytime compression sleeve during the DPRE program.
Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
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.
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).
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.
Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
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.
Interventions
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Compression sleeve, worn during exercise
Participants wear their daytime compression sleeve during the DPRE program.
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.
Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
FEMALE
No
Sponsors
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AHS Cancer Control Alberta
OTHER
Responsible Party
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Locations
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Cross Cancer Institute
Edmonton, Alberta, Canada
Countries
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References
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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.
Related Links
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Link to the pilot study
Other Identifiers
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IIT-0016
Identifier Type: -
Identifier Source: org_study_id
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