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Completed

NCT Number: NCT02992782

Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management

Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related lymphedema. Our objective is to determine if breast cancer survivors are willing and able to wear advanced compression while exercising and if the combination will help to reduce their lymphedema. Twenty-four breast cancer survivors from Edmonton, Alberta will be enrolled in the one-year long study.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

About this study

Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer. Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy. Compression therapy and exercise are commonly prescribed treatment to help reduce the arm swelling and to maintain the result. The exercise that is usually prescribed for lymphedema is called decongestive remedial exercise. It involves active, non-resisted movements that follow a specific order from proximal to distal and back proximally. The exercises start at the neck, move to the chest wall and then down the arm, and back.

Two different types of compression garments have been proposed to help reduce swelling when women are exercising. One compression garment is made with a stiffer, less elastic type of material and is called a "flat-knit" garment. The other garment, the "Adjustable Compression Wrap" is a garment with an adjustable elastic strapping system that helps to reinforce the compression on the arm. Recent research suggests that these specialized garments enhance the muscle pump effect on lymph flow; however, no research has been conducted to test whether this actually results in improvements in arm lymphedema volume.

Resistance exercise training helps to improve arm flexibility, strength, function, and quality of life in breast cancer survivors. Recent evidence has shown that breast cancer survivors with lymphedema, can safely perform resistance training (strength training), however, there is no impact (better or worse) on arm lymphedema volume.

To date, no studies have been performed combining all potential therapeutic approaches for lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and compression therapy. Women in the experimental arms of this study will wear a compression garment when performing progressive resistance exercise that follows the decongestive sequence. We will examine the effect of the combined intervention on arm lymphedema volume, function and quality of life.

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 unilateral mild to moderate lymphedema of at least 200 ml or 10% inter-limb volume difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in hand and forearm region;
  • 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, including manual lymph drainage and intermittent pneumatic compression during the supervised intervention period of the study

Exclusion criteria

  • Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
  • Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
  • Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
  • Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
  • Have a body mass index (BMI) greater than 40 kg/m2.

Treatment and study plan

Standard Care

Behavioral

Home program of decongestive exercise and daily use of a compression sleeve

Exercise and Compression Garment

Behavioral

Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve

Exercise and Adjustable Compression Wrap

Behavioral

Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve

Primary outcomes

  1. Arm Lymphedema Volume

    Time frame: Change from baseline to 12 weeks

    Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)

Secondary outcomes

  1. Bioimpedance Analysis

    Time frame: Change from baseline to 12 weeks

    Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm

  2. Upper body strength

    Time frame: Change baseline to 12 weeks

    One repetition maximum strength for bench press and seated row

  3. Lower body strength

    Time frame: Change baseline to 12 weeks

    One repetition maximum strength for leg press

  4. Shoulder range of motion

    Time frame: Change baseline to 12 weeks

    Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements

  5. Lymphedema International Classification of Functioning (LYMPH-ICF)

    Time frame: Change baseline to 12-weeks

    Lymphedema-specific quality of life

  6. Rand Short-form (SF): 36

    Time frame: Change baseline to 12-weeks

    General health-related quality of life

  7. Godin Leisure-time Questionnaire

    Time frame: Change baseline to 12-weeks

    Physical activity level in previous 4-week period

  8. Body composition

    Time frame: Change baseline to 12-weeks

    Body mass index as calculated by body weight and height metrics

  9. Body Image

    Time frame: Change baseline to 12-weeks

    Body Image and Relationship in past month

  10. Tissue Composition

    Time frame: Change baseline to 12-weeks

    Magnetic Resonance Imaging: fat, water and muscle mass

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study title

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

Acronym: DREAM

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Dec 14, 2016
Registry last updated
Jan 13, 2026

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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