An interventional study of Standard Care and Exercise and Compression Garment in Breast Neoplasm and Lymphedema, sponsored by University of Alberta. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
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
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
Home program of decongestive exercise and daily use of a compression sleeve
Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
Arm Lymphedema Volume
Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Time frame: Change from baseline to 12 weeks
Bioimpedance Analysis
Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Time frame: Change from baseline to 12 weeks
Upper body strength
One repetition maximum strength for bench press and seated row
Time frame: Change baseline to 12 weeks
Lower body strength
One repetition maximum strength for leg press
Time frame: Change baseline to 12 weeks
Shoulder range of motion
Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements
Time frame: Change baseline to 12 weeks
Lymphedema International Classification of Functioning (LYMPH-ICF)
Lymphedema-specific quality of life
Time frame: Change baseline to 12-weeks
Rand Short-form (SF): 36
General health-related quality of life
Time frame: Change baseline to 12-weeks
Godin Leisure-time Questionnaire
Physical activity level in previous 4-week period
Time frame: Change baseline to 12-weeks
Body composition
Body mass index as calculated by body weight and height metrics
Time frame: Change baseline to 12-weeks
Body Image
Body Image and Relationship in past month
Time frame: Change baseline to 12-weeks
Tissue Composition
Magnetic Resonance Imaging: fat, water and muscle mass
Time frame: Change baseline to 12-weeks
Plan to share: Yes — On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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