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The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema

The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05610579
Enrollment
34
Registered
2022-11-09
Start date
2022-11-14
Completion date
2023-02-28
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Breast Cancer

Keywords

compression therapy, lymphedema, exercise

Brief summary

The aim of this study to investigate 24 hours of effects of remedial exercises with and without compression therapy on severity of lymphedema and symptoms of the lymphedema The present study is designed as a non-drug clinical trial. The patients will complete two remedial exercise sessions, one without and one with compression in a randomized order separated by a 3-day wash-out period.The main questions it aims to answer are 1. The 24 hour effects of remedial exercises with and without compression therapy on the severity of lymphedema are different in individuals with lymphedema associated with breast cancer surgery. 2. The 24 hour effects of remedial exercises with and without compression therapy on the symptoms of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.

Interventions

OTHERRemedial exercise

Remedial exercise program will be taught by qualified physiotherapist. Patients will be practiced to the exercise 3 sets of 15 repetitions without compression. Patients will be monitored telephonically in the washout period for remain the routine activities.

Multi-layered short stretch bandaging will be applied for 23 hour. Patients will be practiced to the exercise 3 sets of 15 repetitions with compression bandage. The bandage will be removed at the same time the next day. Patients will be monitored telephonically in the washout period for remain the routine activities.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- Age between 18 and 75 years * 2 cm or greater difference between the affected and unaffected arms in women with breast cancer related lymphedema * At least 12 months after breast cancer surgery end

Exclusion criteria

* current recurrence of breast cancer * bilateral involvement * active infection * presence of metastases * diabetes mellitus * hypertension * pre-existing neuromusculoskeletal and neurological conditions * edema due to other reasons (e.g., primary lymphedema, lung and heart diseases)

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonographic measurementsChange in symptoms related to lymphedema from baseline up to end of 24 hourUltrasound imaging was performed using a 5-13-Megahertz linear probe. During the procedure, the participants will be seated with their forearms supinated and extended on a pillow. Measurements will be made bilaterally from 10 cm distal and proximal to the elbow bend, from the midpoint of the medial and lateral epicondyles, along the line parallel to the arm axis.
Circumference measurementChange in symptoms related to lymphedema from baseline up to end of 24 hourThe severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Bioimpedance spectroscopyChange in symptoms related to lymphedema from baseline up to end of 24 hourThe patient is in the supine position with his arms and legs not touching each other. This measurement will be made using the Impedimed L-Dex U 400 device. The reference point is the top of both hands and the dorsum of the foot. This measurement is made using superficial electrodes and there is no risk. The percentage of fluid will be calculated by making a measurement for both arms.

Secondary

MeasureTime frameDescription
symptoms of lymphedemaChange in symptoms related to lymphedema from baseline up to end of 24 hourFour participant-reported lymphedema symptoms were assessed: swelling, heaviness, tightness commonly associated with BCRL. Using a 100 mm visual analogue scale (VAS), participants marked on it the extent to which they perceived their arm to be swollen, heavy or tight and pain during the past month, with 0 being not at all and 10 being extremely.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026