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Completed

NCT Number: NCT05022823

Exercise and Compression for Lymphedema

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.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Compression sleeve, worn during exercise

Device

Participants wear their daytime compression sleeve during the DPRE program.

Adjustable Compression (AC) garment, worn during exercise

Device

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

Device

Compression sleeve worn for at least 12 hours per day, seven days a week.

Decongestive Progressive Resistance Exercise program

Behavioral

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

Home Exercise Program

Behavioral

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.

Primary outcomes

  1. Change in Lymphedema Arm Volume

    Time frame: Up to 24 weeks

    Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in Grip Strength

    Time frame: Up to 24 weeks

    The Jamar hydraulic hand dynamometer will be used to measure grip strength.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

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

Acronym: DREAM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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