Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management

NCT02992782 | Completed

• 1 other identifier: HREBA - CC 16-1026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasm; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Arm Lymphedema Volume

  Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)

  Change from baseline to 12 weeks

Secondary Outcomes (10)

• Bioimpedance Analysis

  Change from baseline to 12 weeks

• Upper body strength

  Change baseline to 12 weeks

• Lower body strength

  Change baseline to 12 weeks

• Shoulder range of motion

  Change baseline to 12 weeks

• Lymphedema International Classification of Functioning (LYMPH-ICF)

  Change baseline to 12-weeks

Study Arms (3)

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.

Behavioral: Standard Care

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.

Behavioral: Exercise and Compression Garment

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.

Behavioral: Exercise and Adjustable Compression Wrap

Interventions

Standard Care BEHAVIORAL

Home program of decongestive exercise and daily use of a compression sleeve

Standard Care

Exercise and Compression Garment BEHAVIORAL

Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve

Exercise and Compression Garment

Exercise and Adjustable Compression Wrap BEHAVIORAL

Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve

Exercise and Adjustable Compression Wrap

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 lymphedema of at least 200 ml or 10% inter-limb volume difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in hand and forearm region;
• 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, including manual lymph drainage and intermittent pneumatic compression during the supervised intervention period of the study

You may not qualify if:

• Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
• Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
• Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
• Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
• Have a body mass index (BMI) greater than 40 kg/m2.

Sponsors & Collaborators

• Cross Cancer Institute: collaborator
• University of Alberta: lead

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Standard of Care; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margaret L McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 14, 2016
• Study Start: June 1, 2017
• Primary Completion: August 14, 2023
• Study Completion: August 28, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Not determined
• Access Criteria: Pending

Locations

CA (1)