Clinical trial NCT05022823: Exercise and Compression for Lymphedema
Official title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Keywords: Decongestive Progressive Resistance Exercise
compression sleeve during exercise
adjustable compression garment
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change in Lymphedema Arm Volume
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change in Extracellular Fluid Volume
timeFrame: Up to 24 weeks
measure: Change in Muscle Strength
timeFrame: Up to 24 weeks
measure: Change in Grip Strength
timeFrame: Up to 24 weeks
measure: Change in Shoulder Range of Motion
timeFrame: Up to 24 weeks
measure: Health-Related Quality of Life (Lymph-ICF)
timeFrame: Up to 24 weeks
measure: Health-Related Quality of Life (SF-36)
timeFrame: Up to 24 weeks
measure: Physical Activity Level
timeFrame: Up to 24 weeks
measure: Exercise and Compression Adherence
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References:
citation: 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.