Exercise and Compression for Lymphedema (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: NCT05022823 |
|
Recruitment Status :
Recruiting
First Posted : August 26, 2021
Last Update Posted : June 1, 2022
|
Sponsor:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
AHS Cancer Control Alberta
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Related Lymphedema | Device: Compression sleeve, worn during exercise Device: Adjustable Compression (AC) garment, worn during exercise Device: Compression sleeve, daytime wear Behavioral: Decongestive Progressive Resistance Exercise program Behavioral: Home exercise program | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 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 Randomized Control Trial |
| Estimated Study Start Date : | May 27, 2022 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | May 31, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Standard of Care
Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)
|
Device: Compression sleeve, daytime wear
Compression sleeve worn for at least 12 hours per day, seven days a week. Behavioral: Home exercise program 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. |
|
Experimental: DPRE + compression sleeve during exercise
Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)
|
Device: Compression sleeve, worn during exercise
Participants wear their daytime compression sleeve during the DPRE program. Device: Compression sleeve, daytime wear Compression sleeve worn for at least 12 hours per day, seven days a week. Behavioral: Decongestive Progressive Resistance Exercise program 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. Other Name: DPRE |
|
Experimental: DPRE + AC garment during exercise
Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).
|
Device: Adjustable Compression (AC) garment, worn during exercise
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. Device: Compression sleeve, daytime wear Compression sleeve worn for at least 12 hours per day, seven days a week. Behavioral: Decongestive Progressive Resistance Exercise program 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. Other Name: DPRE |
Primary Outcome Measures :
- Change in Lymphedema Arm Volume [ Time Frame: Up to 24 weeks ]Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
Secondary Outcome Measures :
- Change in Extracellular Fluid Volume [ Time Frame: Up to 24 weeks ]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 [ Time Frame: Up to 24 weeks ]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 [ Time Frame: Up to 24 weeks ]The Jamar hydraulic hand dynamometer will be used to measure grip strength.
- Change in Shoulder Range of Motion [ Time Frame: Up to 24 weeks ]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) [ Time Frame: Up to 24 weeks ]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) [ Time Frame: Up to 24 weeks ]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 [ Time Frame: Up to 24 weeks ]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 [ Time Frame: Up to 24 weeks ]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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 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);
- 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.
Exclusion Criteria:
- Are undergoing or are scheduled to receive chemotherapy, radiotherapy or biological therapy
- 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;
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): NCT05022823
Contacts
| Contact: Margaret McNeely, PhD | 780-248-1531 | mmcneely@ualberta.ca |
Locations
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
Sponsors and Collaborators
AHS Cancer Control Alberta
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AHS Cancer Control Alberta |
| ClinicalTrials.gov Identifier: | NCT05022823 |
| Other Study ID Numbers: |
IIT-0016 |
| First Posted: | August 26, 2021 Key Record Dates |
| Last Update Posted: | June 1, 2022 |
| Last Verified: | May 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AHS Cancer Control Alberta:
|
Decongestive Progressive Resistance Exercise compression sleeve during exercise adjustable compression garment |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Breast Cancer Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases Postoperative Complications Pathologic Processes |