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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992782
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE December 10, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date December 1, 2022
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2016)
Arm Lymphedema Volume [ Time Frame: Change from baseline to 12 weeks ]
Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Bioimpedance Analysis [ Time Frame: Change from baseline to 12 weeks ]
    Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
  • Upper body strength [ Time Frame: Change baseline to 12 weeks ]
    One repetition maximum strength for bench press and seated row
  • Lower body strength [ Time Frame: Change baseline to 12 weeks ]
    One repetition maximum strength for leg press
  • 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
  • Lymphedema International Classification of Functioning (LYMPH-ICF) [ Time Frame: Change baseline to 12-weeks ]
    Lymphedema-specific quality of life
  • Rand Short-form (SF): 36 [ Time Frame: Change baseline to 12-weeks ]
    General health-related quality of life
  • Godin Leisure-time Questionnaire [ Time Frame: Change baseline to 12-weeks ]
    Physical activity level in previous 4-week period
  • Body composition [ Time Frame: Change baseline to 12-weeks ]
    Body mass index as calculated by body weight and height metrics
  • Body Image [ Time Frame: Change baseline to 12-weeks ]
    Body Image and Relationship in past month
  • Tissue Composition [ Time Frame: Change baseline to 12-weeks ]
    Magnetic Resonance Imaging: fat, water and muscle mass
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2016)
  • Bioimpedance Analysis [ Time Frame: Change from baseline to 12 weeks ]
    Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
  • Upper body strength [ Time Frame: Change baseline to 12 weeks ]
    One repetition maximum strength for bench press and seated row
  • Lower body strength [ Time Frame: Change baseline to 12 weeks ]
    One repetition maximum strength for leg press
  • 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
  • Lymphedema International Classification of Functioning (LYMPH-ICF) [ Time Frame: Change baseline to 12-weeks ]
    Lymphedema-specific quality of life
  • Rand Short-form (SF): 36 [ Time Frame: Change baseline to 12-weeks ]
    General health-related quality of life
  • Godin Leisure-time Questionnaire [ Time Frame: Change baseline to 12-weeks ]
    Physical activity level in previous 4-week period
  • Body composition [ Time Frame: Change baseline to 12-weeks ]
    Body mass index as calculated by body weight and height metrics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management
Official Title  ICMJE Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasm
  • Lymphedema
Intervention  ICMJE
  • Behavioral: Standard Care
    Home program of decongestive exercise and daily use of a compression sleeve
  • Behavioral: Exercise and Compression Garment
    Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
  • Behavioral: Exercise and Adjustable Compression Wrap
    Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard Care
  • 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.
    Intervention: Behavioral: Exercise and Compression Garment
  • 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.
    Intervention: Behavioral: Exercise and Adjustable Compression Wrap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2016)
24
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margaret L McNeely, PhD 780-248-1531 mmcneely@ualberta.ca
Contact: Mona Al Onazi, BSc 780-492-6007 alonazi@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992782
Other Study ID Numbers  ICMJE HREBA - CC 16-1026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
Time Frame: Not determined
Access Criteria: Pending
Current Responsible Party University of Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cross Cancer Institute
Investigators  ICMJE
Principal Investigator: Margaret L McNeely, PhD University of Alberta
PRS Account University of Alberta
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP