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Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management (DREAM)

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ClinicalTrials.gov Identifier: NCT02992782
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Lymphedema Behavioral: Standard Care Behavioral: Exercise and Compression Garment Behavioral: Exercise and Adjustable Compression Wrap Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Care
Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise.
 Behavioral: Standard Care
Home program of decongestive exercise and daily use of a compression sleeve
Experimental: Exercise and Compression Garment
Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home.
 Behavioral: Exercise and Compression Garment
Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
Experimental: Exercise and Adjustable Compression Wrap
Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home.
 Behavioral: Exercise and Adjustable Compression Wrap
Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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;
  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, including manual lymph drainage and intermittent pneumatic compression during the supervised intervention period of the study

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992782


Contacts
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Contact: Margaret L McNeely, PhD 780-248-1531 mmcneely@ualberta.ca
Contact: Mona Al Onazi, BSc 780-492-6007 alonazi@ualberta.ca

Locations
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Canada, Alberta
University of Alberta/ Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Margaret McNeely, PhD    780-248-1531    mmcneely@ualberta.ca   
Principal Investigator: Margaret L. McNeely, PhD         
Sponsors and Collaborators
University of Alberta
Cross Cancer Institute
Investigators
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Principal Investigator: Margaret L McNeely, PhD University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02992782     History of Changes
Other Study ID Numbers: HREBA - CC 16-1026
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes