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Exercise and Compression for Lymphedema (DREAM)

Primary Purpose

Breast Cancer Related Lymphedema

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Compression sleeve, worn during exercise
Adjustable Compression (AC) garment, worn during exercise
Compression sleeve, daytime wear
Decongestive Progressive Resistance Exercise program
Home exercise program
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Related Lymphedema focused on measuring Decongestive Progressive Resistance Exercise, compression sleeve during exercise, adjustable compression garment

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 BCRL of at least 200 ml inter-limb volume difference or regional lymphedema: defined as a minimal volume difference of 100 ml in a segment of the arm (e.g. hand and forearm region, elbow and upper arm);
  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 that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week RCT period of the study.

Exclusion Criteria:

  1. Are undergoing or are scheduled to receive chemotherapy, radiotherapy or biological therapy
  2. Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease;
  3. 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;
  4. Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;

Sites / Locations

  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard of Care

DPRE + compression sleeve during exercise

DPRE + AC garment during exercise

Arm Description

Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)

Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).

Outcomes

Primary Outcome Measures

Change in Lymphedema Arm Volume
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).

Secondary Outcome Measures

Change in Extracellular Fluid Volume
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.
Change in Muscle Strength
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.
Change in Grip Strength
The Jamar hydraulic hand dynamometer will be used to measure grip strength.
Change in Shoulder Range of Motion
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.
Health-Related Quality of Life (Lymph-ICF)
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.
Health-Related Quality of Life (SF-36)
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.
Physical Activity Level
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.
Exercise and Compression Adherence
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).

Full Information

First Posted
August 16, 2021
Last Updated
September 28, 2023
Sponsor
AHS Cancer Control Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05022823
Brief Title
Exercise and Compression for Lymphedema
Acronym
DREAM
Official Title
Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphedema
Keywords
Decongestive Progressive Resistance Exercise, compression sleeve during exercise, adjustable compression garment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)
Arm Title
DPRE + compression sleeve during exercise
Arm Type
Experimental
Arm Description
Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)
Arm Title
DPRE + AC garment during exercise
Arm Type
Experimental
Arm Description
Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).
Intervention Type
Device
Intervention Name(s)
Compression sleeve, worn during exercise
Intervention Description
Participants wear their daytime compression sleeve during the DPRE program.
Intervention Type
Device
Intervention Name(s)
Adjustable Compression (AC) garment, worn during exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Compression sleeve, daytime wear
Intervention Description
Compression sleeve worn for at least 12 hours per day, seven days a week.
Intervention Type
Behavioral
Intervention Name(s)
Decongestive Progressive Resistance Exercise program
Other Intervention Name(s)
DPRE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home exercise program
Intervention Description
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 Outcome Measure Information:
Title
Change in Lymphedema Arm Volume
Description
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Change in Extracellular Fluid Volume
Description
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.
Time Frame
Up to 24 weeks
Title
Change in Muscle Strength
Description
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.
Time Frame
Up to 24 weeks
Title
Change in Grip Strength
Description
The Jamar hydraulic hand dynamometer will be used to measure grip strength.
Time Frame
Up to 24 weeks
Title
Change in Shoulder Range of Motion
Description
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.
Time Frame
Up to 24 weeks
Title
Health-Related Quality of Life (Lymph-ICF)
Description
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.
Time Frame
Up to 24 weeks
Title
Health-Related Quality of Life (SF-36)
Description
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.
Time Frame
Up to 24 weeks
Title
Physical Activity Level
Description
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.
Time Frame
Up to 24 weeks
Title
Exercise and Compression Adherence
Description
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).
Time Frame
Up to 24 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 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;
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35379618
Citation
Al Onazi MM, Campbell KL, Thompson RB, Ghosh S, Mackey JR, Muir A, McNeely ML. Decongestive progressive resistance exercise with an adjustable compression wrap for breast cancer-related lymphoedema (DREAM): protocol for a randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e053165. doi: 10.1136/bmjopen-2021-053165.
Results Reference
derived
Links:
URL
https://www.clinicaltrials.gov/ct2/show/NCT02992782?term=NCT02992782&draw=2&rank=1
Description
Link to the pilot study

Learn more about this trial

Exercise and Compression for Lymphedema

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