Breast Cancer Related LymphedemaDREAMNCT05022823
Exercise and Compression for Lymphedema
A study testing Compression sleeve, worn during exercise, Adjustable Compression (AC) garment, worn during exercise and Compression sleeve, daytime wear in people with Breast Cancer Related Lymphedema, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Compression sleeve, worn during exercise, Adjustable Compression (AC) garment, worn during exercise and Compression sleeve, daytime wear
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2022to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
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.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Compression sleeve, worn during exercise, Adjustable Compression (AC) garment, worn during exercise, Compression sleeve, daytime wear, Decongestive Progressive Resistance Exercise program, Home exercise program
- Keywords
- Decongestive Progressive Resistance Exercise, compression sleeve during exercise, adjustable compression garment
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression sleeve, worn during exerciseDevice
Participants wear their daytime compression sleeve during the DPRE program.
Adjustable Compression (AC) garment, worn during exerciseDevice
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.
Compression sleeve, daytime wearDevice
Compression sleeve worn for at least 12 hours per day, seven days a week.
Decongestive Progressive Resistance Exercise programBehavioural
Also called DPRE
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.
Home exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day) Receives: Device: Compression sleeve, daytime wear; Behavioral: Home exercise program |
| DPRE + compression sleeve during exercise | Experimental | Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day) Receives: Device: Compression sleeve, worn during exercise; Device: Compression sleeve, daytime wear; Behavioral: Decongestive Progressive Resistance Exercise program |
| DPRE + AC garment during exercise | Experimental | Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day). Receives: Device: Adjustable Compression (AC) garment, worn during exercise; Device: Compression sleeve, daytime wear; Behavioral: Decongestive Progressive Resistance Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lymphedema Arm Volume
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
Measured: Up to 24 weeks
Secondary outcomes (8)
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.
Measured: Up to 24 weeks
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.
Measured: Up to 24 weeks
Change in Grip Strength
The Jamar hydraulic hand dynamometer will be used to measure grip strength.
Measured: Up to 24 weeks
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.
Measured: Up to 24 weeks
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.
Measured: Up to 24 weeks
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.
Measured: Up to 24 weeks
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.
Measured: Up to 24 weeks
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).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start29 Jun 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022823
- Sponsor's protocol ID
- IIT-0016
- Acronym
- DREAM
- Status last verified
- Jun 2025
- First submitted
- 16 Aug 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35379618
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05022823
- Acronym / sponsor ID
- DREAM / IIT-0016
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- Decongestive Progressive Resistance Exercise, compression sleeve during exercise, adjustable compression garment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Compression sleeve, daytime wear, Behavioral: Home exercise programGroup A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day) |
| DPRE + compression sleeve during exercise | Experimental | Device: Compression sleeve, worn during exercise, Device: Compression sleeve, daytime wear, Behavioral: Decongestive Progressive Resistance Exercise programGroup B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day) |
| DPRE + AC garment during exercise | Experimental | Device: Adjustable Compression (AC) garment, worn during exercise, Device: Compression sleeve, daytime wear, Behavioral: Decongestive Progressive Resistance Exercise programGroup C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression sleeve, worn during exerciseParticipants wear their daytime compression sleeve during the DPRE program. | Device | DPRE + compression sleeve during exercise |
| Adjustable Compression (AC) garment, worn during exerciseParticipants 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. | Device | DPRE + AC garment during exercise |
| Compression sleeve, daytime wearCompression sleeve worn for at least 12 hours per day, seven days a week. | Device | DPRE + AC garment during exercise, DPRE + compression sleeve during exercise, Standard of Care |
| Decongestive Progressive Resistance Exercise programAlso: DPRESupervised 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. | Behavioural | DPRE + AC garment during exercise, DPRE + compression sleeve during exercise |
| Home exercise programParticipants 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. | Behavioural | Standard of Care |
Primary outcome
Change in Lymphedema Arm Volume
Time frame: Up to 24 weeks
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
8 secondary outcomes
Change in Extracellular Fluid Volume
Time frame: Up to 24 weeks
Change in Muscle Strength
Time frame: Up to 24 weeks
Change in Grip Strength
Time frame: Up to 24 weeks
Change in Shoulder Range of Motion
Time frame: Up to 24 weeks
Health-Related Quality of Life (Lymph-ICF)
Time frame: Up to 24 weeks
Health-Related Quality of Life (SF-36)
Time frame: Up to 24 weeks
Physical Activity Level
Time frame: Up to 24 weeks
Exercise and Compression Adherence
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 35379618Al 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.
- Link to the pilot studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression sleeve, worn during exercise, Adjustable Compression (AC) garment, worn during exercise and Compression sleeve, daytime wear in people with Breast Cancer Related Lymphedema, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lymphedema Arm Volume (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.