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

Primary Purpose

Breast Neoplasm, Lymphedema

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Care
Exercise and Compression Garment
Exercise and Adjustable Compression Wrap
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta/ Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Care

Exercise and Compression Garment

Exercise and Adjustable Compression Wrap

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bioimpedance Analysis
Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Upper body strength
One repetition maximum strength for bench press and seated row
Lower body strength
One repetition maximum strength for leg press
Shoulder range of motion
Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements
Lymphedema International Classification of Functioning (LYMPH-ICF)
Lymphedema-specific quality of life
Rand Short-form (SF): 36
General health-related quality of life
Godin Leisure-time Questionnaire
Physical activity level in previous 4-week period
Body composition
Body mass index as calculated by body weight and height metrics
Body Image
Body Image and Relationship in past month
Tissue Composition
Magnetic Resonance Imaging: fat, water and muscle mass

Full Information

First Posted
December 10, 2016
Last Updated
September 2, 2023
Sponsor
University of Alberta
Collaborators
Cross Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02992782
Brief Title
Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management
Acronym
DREAM
Official Title
Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Cross Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise and Compression Garment
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise and Adjustable Compression Wrap
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Home program of decongestive exercise and daily use of a compression sleeve
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Compression Garment
Intervention Description
Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Adjustable Compression Wrap
Intervention Description
Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
Primary Outcome Measure Information:
Title
Arm Lymphedema Volume
Description
Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Bioimpedance Analysis
Description
Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Time Frame
Change from baseline to 12 weeks
Title
Upper body strength
Description
One repetition maximum strength for bench press and seated row
Time Frame
Change baseline to 12 weeks
Title
Lower body strength
Description
One repetition maximum strength for leg press
Time Frame
Change baseline to 12 weeks
Title
Shoulder range of motion
Description
Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements
Time Frame
Change baseline to 12 weeks
Title
Lymphedema International Classification of Functioning (LYMPH-ICF)
Description
Lymphedema-specific quality of life
Time Frame
Change baseline to 12-weeks
Title
Rand Short-form (SF): 36
Description
General health-related quality of life
Time Frame
Change baseline to 12-weeks
Title
Godin Leisure-time Questionnaire
Description
Physical activity level in previous 4-week period
Time Frame
Change baseline to 12-weeks
Title
Body composition
Description
Body mass index as calculated by body weight and height metrics
Time Frame
Change baseline to 12-weeks
Title
Body Image
Description
Body Image and Relationship in past month
Time Frame
Change baseline to 12-weeks
Title
Tissue Composition
Description
Magnetic Resonance Imaging: fat, water and muscle mass
Time Frame
Change baseline to 12-weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret L McNeely, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta/ Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
IPD Sharing Time Frame
Not determined
IPD Sharing Access Criteria
Pending

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Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management

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