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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Lymphedema||Behavioral: Standard Care Behavioral: Exercise and Compression Garment Behavioral: Exercise and Adjustable Compression Wrap||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||September 30, 2023|
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.
Behavioral: Standard Care
Home program of decongestive exercise and daily use of a compression sleeve
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.
Behavioral: Exercise and Compression Garment
Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
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.
Behavioral: Exercise and Adjustable Compression Wrap
Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
- Arm Lymphedema Volume [ Time Frame: Change from baseline to 12 weeks ]Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
- 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
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): NCT02992782
|Contact: Margaret L McNeely, PhDemail@example.com|
|Contact: Mona Al Onazi, BScfirstname.lastname@example.org|
|University of Alberta/ Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 2G4|
|Contact: Margaret McNeely, PhD 780-248-1531 email@example.com|
|Principal Investigator: Margaret L. McNeely, PhD|
|Principal Investigator:||Margaret L McNeely, PhD||University of Alberta|