Diaphragmatic Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema

NCT05483569 | Unknown

• 1 other identifier: 2022/0406
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of multidimensional breathing exercises and fascial release techniques performed in addition to the conventional treatment program on the treatment of lymphatic fluid in women with lower extremity lymphedema due to gynecological cancer treatment, and the reflection of these practices on the functional level, sleep and quality of life.

Conditions

Lower Extremity Lymphedema

Keywords

Lower Extremity Lymphedema; Diaphragmatic Breathing Exercises; Fascial Release Techniques; Gynecological Cancer Treatment

Outcome Measures

Primary Outcomes (10)

• Data Record

  Demographic, clinical and lymphedema-related data will be recorded with face-to-face interviews.

  Baseline

• Leg circumference measurement

  Both leg circumference measurements will be taken at 4 cm intervals from the medial malleolus. These values will then be converted to volumetric measurement using the ACOLS Limb Volume Calculation program.

  Change from baseline leg circumference measurement at week 3 and week 7.

• Functional Evaluation

  The Lower Extremity Functional Scale will be used to determine the functional levels of individuals. The lower extremity functional scale consists of 20 items. Each item is scored between 0-4 and evaluated in 5 options. These options are: extreme difficulty/inability to perform the activity, quite difficult, moderate difficulty, a little difficulty and no difficulty. The total score ranges from 0-80, with higher scores representing better functional level. Individuals will be asked to mark the difficulties they have experienced or will experience in activities related to the cause of lymphedema, and the total score will be calculated.

  Change from baseline Lower Extremity Functional Scale at week 3 and week 7.

• Evaluation of Sleep Quality

  It will be assessed by the Pittsburgh Sleep Quality Index, which evaluates the sleep quality of the individual for the last month, includes a total of 24 questions. 19 of these are self-report questions and are answered by the patient himself. Five questions are answered by the patient's spouse or roommate and are used for clinical information only and are not included in the scoring. Each question is evaluated with a number from 0 to 3. The sum of the scores of the seven components gives the total score. Sleep quality of those with a total score of 5 or less was "good"; Those with a score above 5 are considered to have "poor" sleep quality.

  Change from baseline Pittsburgh Sleep Quality Index at week 3 and week 7.

• Evaluation of Quality of Life

  The disease-specific quality of life of individuals will be evaluated using the Lymphedema Quality of Life Questionnaire. It is designed as two separate forms as lower extremity and upper extremity. A leg questionnaire will be applied to individuals. The questionnaire has 4 sub-dimensions: symptoms, body image, appearance, function, and mode. It contains 26 items in total. Individuals will be asked to tick the box that best describes how they feel about each of the questions, and the total score will be calculated.

  Change from baseline Lymphedema Quality of Life Questionnaire at week 3 and week 7.

• Passive Tone

  Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

  Change from baseline passive tone of myofascial tissues at week 3 and week 7.

• Stiffness

  Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

  Change from baseline Stiffness of myofascial tissues at week 3 and week 7.

• Decrement

  Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

  Change from baseline Decrement of myofascial tissues at week 3 and week 7.

• Creep

  Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

  Change from baseline Creep of myofascial tissues at week 3 and week 7.

• Relaxation time

  Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

  Change from baseline Relaxation time of myofascial tissues at week 3 and week 7.

Study Arms (2)

Complex Decongestive Physiotherapy

OTHER

CDP program consisting of 4 parameters will be applied to this group. These parameters are MLD, Skin care, Multi-layer bandage application and decongestive exercises. In addition, the Placebo Facial Release technique will be performed by keeping the physiotherapist's hand in contact with the patient's abdominal region without applying any pressure and tension during the breathing exercises. Participants will be treated for a total of 3 weeks, 5 days a week. Each treatment session will last 45 minutes.

Other: Complex Decongestive Physiotherapy

Multidimensional Diaphragmatic Breathing Exercises and Facial Release Technique

EXPERIMENTAL

CDP program consisting of 4 parameters will be applied to this group. These parameters are MLD, Skin care, Multi-layer bandage application and decongestive exercises. In addition, Multidimensional Diaphragmatic Breathing Exercises and Facial Release technique will be applied. These two treatments consist of these sub-exercises. These; Mechanical nose opening techniques, Intermittent Sniffing exercise, Diaphragm Awareness and Exercise Short Protocol, Thorax mobilization exercises, Myofascial diaphragm release techniques, Myofascial release exercises and postures and, Pelvic floor myofascial release postures. Participants will be treated for a total of 3 weeks, 5 days a week. Each treatment session will last 45 minutes.

Other: Multidimensional Diaphragmatic Breathing Exercises; Other: Facial Release Technique

Interventions

Complex Decongestive Physiotherapy OTHER

Complete or complex decongestive physiotherapy (CDP) is a treatment for lymphedema, a condition in which excess fluid (lymph) collects in a part of the body. Damage to the lymph nodes or vessels, or a blockage leading to chronic swelling, usually causes lymphedema.

Complex Decongestive Physiotherapy

Multidimensional Diaphragmatic Breathing Exercises OTHER

Diaphragmatic breathing is an exercising technique to help strengthen your diaphragm and fill your lungs with air more efficiently.

Multidimensional Diaphragmatic Breathing Exercises and Facial Release Technique

Facial Release Technique OTHER

Fascial release is a manual therapy method that is applied holistically to the muscles and surrounding fascia through mechanical stimulation. It is a comprehensive approach to the evaluation and treatment of the muscular and fascia system in the body.

Multidimensional Diaphragmatic Breathing Exercises and Facial Release Technique

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 25-65
• Having unilateral lower extremity lymphedema (including/not including the trunk) due to gynecological cancer diagnosis and treatment method.
• Having Stage 1 and 2 lymphedema according to the International Society of Lymphology (ISL) classification
• Having situation that prevents the application of manual lymph drainage (cardiac edema, acute deep vein thrombus, acute renal failure, acute pulmonary edema, etc.)
• Having a condition that prevents pressure application (arterial insufficiency, pressure intolerance, etc.)
• Not having received conservative treatment for lymphedema for at least 6 months

You may not qualify if:

• Having history of metastases
• Having radiogenic fibrosis in the abdomino-pelvic region
• Having additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect lower extremity functions
• Having connective tissue disease that will affect tissue properties
• Having diseases (cardiac edema, peripheral artery disease, etc.) that prevent MLD and/or bandage application
• Continuation of Radiotherapy (Must have ended at least 3 months ago) and Chemotherapy applications
• Using sedatives and/or muscle relaxants that may alter muscle tone.
• Having any surgical intervention for lymphedema
• Being diagnosed with obesity (BMI\>30)

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34862, Turkey (Türkiye)

Location

Related Publications (3)

• Yoshihara M, Shimono R, Tsuru S, Kitamura K, Sakuda H, Oguchi H, Hirota A. Risk factors for late-onset lower limb lymphedema after gynecological cancer treatment: A multi-institutional retrospective study. Eur J Surg Oncol. 2020 Jul;46(7):1334-1338. doi: 10.1016/j.ejso.2020.01.033. Epub 2020 Jan 31.

  PMID: 32146054 BACKGROUND

• Borman P, Yaman A, Denizli M, Karahan S. The Reliability and Validity of Lymphedema Quality of Life Questionnaire-Leg in Turkish Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Feb;18(1):42-48. doi: 10.1089/lrb.2018.0048. Epub 2019 May 24.

  PMID: 31135275 BACKGROUND

• Hruby RJ, Martinez ES. The Lymphatic System: An Osteopathic Review. Cureus. 2021 Jul 17;13(7):e16448. doi: 10.7759/cureus.16448. eCollection 2021 Jul.

  PMID: 34422479 BACKGROUND

Study Officials

• Nilüfer Kablan, Asst. Prof.

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayça Evkaya Acar, MSc

CONTACT

(0216) 280 33 33; ayca.evkaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be divided into two groups using the block randomization method. Participants will be randomly distributed into 2 blocks of 15 participants. Each group using random number generation technique by computer. All evaluations will be made by the researcher who did not participate in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: There will be two groups in this study. Each group will consist of 15 women aged 25-65 years with Lower Extremity Lymphedema Caused by Gynecological Cancer Treatment. A total of 30 participants will take part in the study. CDP program and placebo fascial release techniques will be applied to the participants in Group 1 and, in addition to the CDP program, the participants in Group 2 will be given multidimensional diaphragmatic breathing exercises and fascial release techniques will be applied.

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)