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Completed

NCT Number: NCT05610579

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

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.

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Key information

Conditions

Lymphedema, Breast Cancer Behavior Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gülbala Nakip

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Remedial exercise

Other

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.

Compression bandage

Other

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.

Primary outcomes

  1. Ultrasonographic measurements

    Time frame: Change in symptoms related to lymphedema from baseline up to end of 24 hour

    Ultrasound 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.

  2. Circumference measurement

    Time frame: Change in symptoms related to lymphedema from baseline up to end of 24 hour

    The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.

  3. Bioimpedance spectroscopy

    Time frame: Change in symptoms related to lymphedema from baseline up to end of 24 hour

    The 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 outcomes

  1. symptoms of lymphedema

    Time frame: Change in symptoms related to lymphedema from baseline up to end of 24 hour

    Four 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".

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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