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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05022823
Other study ID # IIT-0016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 29, 2022
Est. completion date May 31, 2024

Study information

Verified date September 2023
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Is a female with a history of breast cancer; 2. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection; 3. Has visible and palpable unilateral mild to moderate BCRL of at least 200 ml inter-limb volume difference (full limb) or regional lymphedema: defined as a minimal volume difference of 100 ml or 5% in a segment of the arm (e.g. hand and forearm region, elbow and upper arm) after correcting for arm dominance; 4. Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months; 5. Is in the lymphedema maintenance phase of conservative treatment; 6. 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); 7. 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. 8. Is able to read and understand English. Exclusion Criteria: 1. Are undergoing or are scheduled to receive chemotherapy or radiotherapy 2. Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease; 3. 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; 4. Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;

Study Design


Intervention

Device:
Compression sleeve, worn during exercise
Participants wear their daytime compression sleeve during the DPRE program.
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.
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.
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.

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Lymphedema Arm Volume Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer). Up to 24 weeks
Secondary Change in Extracellular Fluid Volume 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. Up to 24 weeks
Secondary Change in Muscle Strength 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. Up to 24 weeks
Secondary Change in Grip Strength The Jamar hydraulic hand dynamometer will be used to measure grip strength. Up to 24 weeks
Secondary Change in Shoulder Range of Motion 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. Up to 24 weeks
Secondary Health-Related Quality of Life (Lymph-ICF) 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. Up to 24 weeks
Secondary Health-Related Quality of Life (SF-36) 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. Up to 24 weeks
Secondary Physical Activity Level 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. Up to 24 weeks
Secondary Exercise and Compression Adherence 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). Up to 24 weeks
See also
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Completed NCT05776433 - The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life
Recruiting NCT04446494 - Identification and Preservation of Arm Lymphatics N/A
Completed NCT04881604 - Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema N/A
Recruiting NCT04934098 - Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema N/A
Enrolling by invitation NCT04165512 - Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema N/A
Terminated NCT04073823 - A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients N/A
Not yet recruiting NCT06182046 - Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-associated Lymphedema. N/A
Recruiting NCT04690439 - Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema N/A
Recruiting NCT04665882 - Nomogram to Predict Breast Cancer Related Lymphedema N/A
Completed NCT04659564 - Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study N/A

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