Exercise and Compression for Lymphedema (DREAM)

AHS Cancer Control Alberta

Status: Completed

Conditions: Breast Cancer Related Lymphedema

Treatments: Device: Adjustable Compression (AC) garment, worn during exercise; Device: Compression sleeve, daytime wear; Behavioral: Home exercise program; Device: Compression sleeve, worn during exercise; Behavioral: Decongestive Progressive Resistance Exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05022823

IIT-0016

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Home exercise program

Device: Compression sleeve, daytime wear

DPRE + compression sleeve during exercise

Experimental group

Description:

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

Treatment:

Behavioral: Decongestive Progressive Resistance Exercise program

Device: Compression sleeve, worn during exercise

Device: Compression sleeve, daytime wear

DPRE + AC garment during exercise

Experimental group

Description:

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

Treatment:

Behavioral: Decongestive Progressive Resistance Exercise program

Device: Compression sleeve, daytime wear

Device: Adjustable Compression (AC) garment, worn during exercise