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| Name | Class |
|---|---|
| Cross Cancer Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | 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. |
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| Exercise and Compression Garment | Experimental | 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. |
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| Exercise and Adjustable Compression Wrap | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | Home program of decongestive exercise and daily use of a compression sleeve |
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| Measure | Description | Time Frame |
|---|---|---|
| Arm Lymphedema Volume | Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany) | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bioimpedance Analysis | Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm | Change from baseline to 12 weeks |
| Upper body strength | One repetition maximum strength for bench press and seated row |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret L McNeely, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta/ Cross Cancer Institute | Edmonton | Alberta | T6G 2G4 | Canada |
On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Exercise and Compression Garment | Behavioral | Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve |
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| Exercise and Adjustable Compression Wrap | Behavioral | Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve |
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| Change baseline to 12 weeks |
| Lower body strength | One repetition maximum strength for leg press | Change baseline to 12 weeks |
| Shoulder range of motion | Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements | Change baseline to 12 weeks |
| Lymphedema International Classification of Functioning (LYMPH-ICF) | Lymphedema-specific quality of life | Change baseline to 12-weeks |
| Rand Short-form (SF): 36 | General health-related quality of life | Change baseline to 12-weeks |
| Godin Leisure-time Questionnaire | Physical activity level in previous 4-week period | Change baseline to 12-weeks |
| Body composition | Body mass index as calculated by body weight and height metrics | Change baseline to 12-weeks |
| Body Image | Body Image and Relationship in past month | Change baseline to 12-weeks |
| Tissue Composition | Magnetic Resonance Imaging: fat, water and muscle mass | Change baseline to 12-weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |